Made some headway today.

Mom, is currently not on any treatment, but I went to the START Cancer Care center and spoke with a wonderful woman who shared the faith and hope that I have in healing my mom. She really cared that all treatment options would be discussed and that every resource be utilized. She was so sweet and I thank God for bringing her forth in our lives.

Mom has signed the release papers so that they can get her complete file and we are one step closer to getting another evaluation and second opinion. 

I would like to point out that we have nothing personal against CTRC or the doctor, but I truly believe it would be irresponsible of us not to seek out a second/third opinion. Our doctor has stated that he is not completely familiar with all treatments for NSCL cancer and it is important that we are presented with all available opportunities. Also, CTRC does not offer all types of treatment. There are several new types such as Proton Therapy (available at MD Anderson) and there is also Photodynamic Therapy (available at the Cancer Treatment Centers of America) and I am not sure if CTRC offers the extensive genetic and molecular typing that the START center does. So, I don't want anyone to think that the Doctors or CTRC is not appreciated, because my family is grateful for what they have done. I just really want to be sure that my mom is getting every opportunity presented to her that is possible. This is an extremely frightening journey and it has been very difficult.

My mom has always been a role model and she has taught me to Never give up and don't take no for an answer. She taught to me to stay strong and to continue whatever journey we are on no matter what obstacles or challenges we face. We will fight this battle together and with all your help.

Thank you and God bless.

-Vanessa

Tomorrow I will ask if they did a complete genetic profile on mom.

Tumors In Majority Of Patients With Advanced Lung Cancer Found To Have Genetic Mutations That Can Be Treated With Targeted Therapies

CHICAGO, IL, June 4, 2011

Mark Kris

Screening tumor samples for cancer-causing genetic mutations can help physicians tailor treatment to specifically target those mutations in patients with advanced lung cancer.
A new study detected one of ten such mutations in 54 percent of the 516 lung cancer patients tested at diagnosis. The results enabled doctors to select the most appropriate drug designed to block the identified mutation and choose other treatment options for those patients whose tumors did not have a mutation.
The results of the multicenter study are being presented today by the study’s lead author, Mark Kris, MD, Chief of the Thoracic Oncology Service at Memorial-Sloan Kettering, at the 2011 annual meeting of the American Society of Clinical Oncology.

“The key to treating men and women with lung cancer lies in understanding the genetic makeup of each person’s tumor,” said Dr. Kris. “Pinpointing specific mutations known to play a role in one-third of lung cancers can help maximize the chance of treatment success with personalized medicine.”

Memorial Sloan-Kettering is one of 14 institutions participating in this ongoing study, which has collaboratively tested a total of 1,000 patients who have been newly diagnosed with stage IV lung cancer that has returned after initial treatment with surgery, chemotherapy, and/or radiation. All 14 hospitals are members of the National Cancer Institute’s Lung Cancer Mutation Consortium (LCMC), an initiative created to identify the frequencies and characteristics of genetic mutations found specifically in lung cancer and research treatments that target them.

Pinpointing specific mutations known to play a role in one-third of lung cancers can help maximize the chance of treatment success with personalized medicine.

Mark Kris, MD, lead author and Chief of the Thoracic Oncology Service at Memorial Sloan-Kettering

The sophisticated technology needed for such extensive testing of cancer-causing, or “driver,” mutations is currently available at only a handful of centers in the world, including Memorial Sloan-Kettering, which began to screen all of its lung cancer patients for driver mutations in 2009.
Study researchers are screening lung tumors using multiplexed assays for mutations in KRAS, EGFR, HER2, BRAF, PIK3CA, AKT1, MEK1, and NRAS and are using flourescence in situ hybridization (FISH) for ALK rearrangements and MET amplifications. The most common mutations found so far have been KRAS (23 percent) and EGFR (17 percent).
Patients whose tumors are found to have the driver mutation EGFR-1, which was discovered by researchers at Memorial Sloan-Kettering and two Harvard institutions in 2004, are treated with the targeted drug erlotinib (Tarceva®), an FDA-approved drug that is currently the standard of care. Patients whose tumors exhibit one of the nine other mutations avoid being treated with erlotinib - which would not likely benefit them - and are offered participation in one of several LCMC-linked clinical trials investigating new medicines that target these specific genetic defects. For example, patients who have the EML-4ALK mutation may enroll in a clinical trial studying the experimental drug crizotinib, which is currently under FDA review for the treatment of lung cancers that have that mutation.
According to Dr. Kris, the next step is to expand this concept of customizing treatment based on a patient’s unique genetic tumor profile to all lung cancers and all stages of lung cancer.

“In fact, this process can work for any cancer and our assay panel already includes important mutations in colorectal cancer (KRAS) and melanoma (BRAF),” noted Dr. Kris. “As additional mutations are discovered by efforts like The Cancer Genome Atlas, these mutations can be quickly included in the routine molecular analyses. At the same time, our investigators will continue researching new therapies that target these genetic abnormalities, providing hope for the 220,000 people diagnosed with lung cancer each year.”

The study was funded by a grant from the American Recovery and Reinvestment Act (ARRA).
Members of the LCMC include Dana Farber Cancer Institute, Boston; Massachusetts General Hospital, Boston; The University of Texas MD Anderson Cancer Center, Houston; Partners Health Cancer Center, Boston; Vanderbilt-Ingram Cancer Center, Nashville; The Sydney Kimmel Comprehensive Cancer Center, Los Angeles; University of Texas Southwestern Medical Center, Dallas; H. Lee Moffit Cancer Center and Research Institute, Tampa; Medical University of South Carolina, Charleston; National Cancer Institute, Bethesda; Vanderbilt University, Nashville; University of Colorado Cancer Center Denver, Aurora; and University of Colorado Denver, Aurora.

IP6 and Inositol- Information from the American Cancer Society website

Inositol Hexaphosphate

Other common name(s): IP6, IP-6, InsP-6, inositol, phytic acid, phytate, myo-inositol hexaphosphate
Scientific/medical name(s): inositol-1,2,3,4,5,6-hexakisphosphate

Description

Inositol hexaphosphate (IP6) is a chemical found in beans, brown rice, corn, sesame seeds, wheat bran, and other high-fiber foods. It is converted into compounds in the body that are used by cells to relay outside messages to the cell nucleus. IP6 also aids the body in its use, or metabolism, of calcium and other minerals.
IP-6 is a very specific form of inositol, and there are several other forms of it found in the human body. It is different, for instance, from myo-inositol, which is another form being studied because of its possible role in illnesses such as depression and anxiety.

Overview

Animal and lab research has found that IP6 may be effective in lowering tumor incidence and slowing tumor growth. However, studies of IP6 have not yet been done in people. Clinical trials are needed to find out how it might work in preventing or treating cancer in humans.

How is it promoted for use?

Proponents call IP6 a "natural cancer fighter" and claim it slows or reverses the growth of various forms of cancer, including breast, colon, and prostate cancers. It is thought to be an antioxidant, a compound that blocks the action of free radicals, activated oxygen molecules that can damage cells. It may help to prevent the abnormal signals that tell a cancer cell to keep growing from reaching the cell's nucleus. Some research shows IP6 slows abnormal cell division and may sometimes transform tumor cells into normal cells. Supporters also claim it effectively prevents kidney stones, high cholesterol, heart disease, and liver disease.
IP6 is one form of inositol. Inositol is a kind of sugar formed by 6 carbon atoms, 6 oxygen atoms, and 12 hydrogen atoms. This combination of atoms can also form glucose, but the atoms are arranged differently in these 2 sugars. There are actually several forms of inositol, each with subtle differences in the arrangement of atoms, with myo-inositol being the most common form. IP6 is formed by substituting phosphate groups (each with a phosphorous and three oxygens) for each of the 6 hydroxyl (an oxygen and hydrogen) groups of inositol. Thus, IP6 is related, yet chemically distinct, from myo-inositol, which is being studied for its possible role in illnesses such as depression and anxiety.

What does it involve?

Many high-fiber food sources contain IP6, and it is also available in pill form as a dietary supplement combining inositol and IP6. Scientists do not know enough about the chemical to recommend a standard supplement dose. It is not known whether taking a supplement provides the same effect as getting IP6 from food sources.

What is the history behind it?

The existence of IP6 has been known for several decades. Interest in its potential anti-cancer properties emerged in the mid-1980s when Abulkalam Shamsuddin, MD, PhD, a pathologist at the University of Maryland, began to conduct research studies on inositol in the lab. He published a book on the subject in 1998. He and other researchers continue to study the effects of IP6.

What is the evidence?

All of the evidence regarding the anticancer effects of IP6 has come from laboratory cell cultures and animal studies. Laboratory studies of cell cultures have shown that IP6 may help put cancer cells on a path toward normal cell death and may help keep them from spreading to other parts of the body. It may also affect the growth of blood vessels that supply the tumor and the immune system in general. These studies have shown IP6 may have activity against cancer of the pancreas, breast, prostate, colon, and other types of cancer. Results of some studies in cells have also suggested that IP6 may help certain chemotherapy or hormone therapy drugs work better.
Studies in animals have found that supplementing the animals' diets with IP6 may help prevent tumors from forming in the prostate, lung, colon, skin, and other areas. While animal and laboratory studies may show a certain compound holds promise as a helpful treatment, further studies are needed to find out if the results apply to humans. One preliminary human study suggested that IP6 may cause regression of precancerous lung changes in smokers. IP6 has not yet been studied in humans as a treatment for cancer.
Inositol hexaphosphate and similar chemicals have also been studied for treating polycystic ovary syndrome, panic disorders, autism, obsessive-compulsive disorders, Alzheimer disease, post-traumatic stress disorders, and depression. Researchers have reached no firm conclusions about its impact on these conditions.

Are there any possible problems or complications?

This product is sold as a dietary supplement in the United States. Unlike drugs (which must be tested before being allowed to be sold), the companies that make supplements are not required to prove to the Food and Drug Administration that their supplements are safe or effective, as long as they don't claim the supplements can prevent, treat, or cure any specific disease.
Some such products may not contain the amount of the herb or substance that is written on the label, and some may include other substances (contaminants). Actual amounts per dose may vary between brands or even between different batches of the same brand.
Most such supplements have not been tested to find out if they interact with medicines, foods, or other herbs and supplements. Even though some reports of interactions and harmful effects may be published, full studies of interactions and effects are not often available. Because of these limitations, any information on ill effects and interactions below should be considered incomplete.
When taken in moderate amounts, IP6 appears to be safe. However, no studies have been done to determine its safety. Some experts advise those who wish to increase their intake of IP6 to add beans, whole grains, and other foods rich in IP-6 to their diets before resorting to supplements.
Inositol hexaphosphate may reduce the body's ability to absorb some minerals such as zinc, calcium, and iron. This concern has been raised mainly in regard infants. IP-6 can also reduce the amounts absorbed from mineral supplements. No studies have tested the safety of IP6 in women who are pregnant or breast-feeding. Relying on this treatment alone and avoiding or delaying conventional medical care for cancer, may have serious health consequences.

Mom had a good weekend!

Even though tuesday was a very difficult day for us, mom has continued her focus on being positive and staying strong. She has been working and keeping life as normal as possible. She has agreed to drink Kombucha tea again which makes me really happy. Its an awesome tea that just really helps boost the immune system and full is of good enzymes and probiotics. Anyway, its just good for her and its healthy. She also has agreed to take the IP6 and Inositol supplements which are also awesome in boosting the immune system. Both of these things are something that in my research and in communicating with other Non small cell lung cancer stage 4 survivors say they take are going on years of survival and some are now No Evidence of Disease (NED). I don't if these will really help and there is no such thing as a miracle cure, but the way I look at it is that its not gonna hurt and in researching it, it really is just good for the immune system. The immune system is very important to monitor in fighting cancer. So, I'm just glad she's taking it anyway. I will post some info on these after.

Anyway, I spent the night on friday with mom and I made spaghetti for dinner. We watched NCIS and talked about seeing another doctor to get another opinion. I showed her some of the discussion forums that I have joined where other people around the world who are fighting this disease come together and talk about what they are going through and how we can all help each other. There are many  people that feel like we do when our doctors just aren't trying enough or don't know enough specifically to want to try. They see that you are stage 4 and don't really see a point in trying. Now that I've said that, other people on these forums come through saying that they were in that same position and decided to go get another opinion (even though their doctors were supposed to be the best in their area as well). Anyway, they got another opinion and are doing extremely well today. They found new doctors who didn't stick with standard protocol and did what they thought would be right for those individual people. I am just hoping that we find another doctor who will fight as hard as my mom is. She really is an inspiration!!

So friday night was good and on saturday we got up and went for a drive to the outlet mall. It was packed with christmas shoppers. Mom and I went to only a couple stores- Yankee candle, bath and bodyworks, and neiman marcus last call. We both got a candle, a hand soap, and sweater (and all at extremely great discount savings plus we had gift cards! Cool). We weren't there too long, maybe an hour and a half and then headed back home in the rain and almost ran out of gas too! After that, we went to mom's good friend and hair dresser Michael and he trimmed her bangs a little and gave her a big hug and kiss. It was nice and I think mom had a good day. We went back to the house had enchiladas for dinner and then mom needed to rest.

This morning, John (my older brother), Darinka (his wife), and I met at the house to get a christmas tree for mom. We picked out a really nice noble fir maybe 8-9feet and we all decorated it together. It was fun and it was really great being together. We had a good weekend.

This week is going to be interesting. Mom will continue to work and I will continue to research treatment options. We are going to discuss options with her doctor on tuesday. He is supposed to be giving us several options and inform us about several clinical trials. Regardless, I am going to be prepared and have lots of questions. I am also hoping to hear from MD Anderson and I will go to the START center and seek out an another evaluation. I just want to be thorough and be sure that all bases are covered.

Keep praying and continue your faith!! God bless.

-Vanessa

Option Tarceva

Possible Benefits of Tarceva

Related Links

• How to Take Tarceva

Maintenance treatment with Tarceva has been shown to extend overall survival time and increase the time until the cancer gets worse.
In a large study in people with advanced NSCLC who received Tarceva as maintenance treatment:

In a large study in people with advanced NSCLC who have not taken Tarceva before and whose cancer has grown or spread after at least 1 prior chemotherapy regimen:

Tarceva may offer convenience

You take the pill by mouth once a day on an empty stomach.
In addition to understanding the benefits of Tarceva, it is also important to know the side effects and safety information about Tarceva. This information appears below.
*Median is the midpoint of a range of numbers. This means that half the patients had a shorter overall survival time and half had a longer overall survival time.
Indications and Usage for Advanced Non-Small Cell Lung Cancer Patients Tarceva is prescribed for patients with advanced-stage Non-small Cell Lung Cancer (NSCLC) whose cancer has not spread or grown after initial treatment with certain types of chemotherapy. (Maintenance treatment)
Tarceva is prescribed for patients with advanced-stage Non-Small Cell Lung Cancer (NSCLC) whose cancer has spread or grown after receiving at least 1 chemotherapy regimen. (2^nd/3^rd-line treatment)
Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.

Important Safety Information

Possible effects on the lungs

There have been reports of serious adverse events involving the lungs in a small number of patients taking Tarceva. These events have included death in some patients. The medical name for these types of events is interstitial (in-tur-STISH-ul) lung disease-like events (or ILD-like events).

Possible effects on the kidneys and liver

Liver and/or kidney problems (including deaths) have been reported in some patients taking Tarceva. Let your healthcare provider (HCP) know if you have a history of liver or kidney disease.

Possible effects on the stomach and intestines

Some patients taking Tarceva have developed a hole in the lining of their stomach or intestines (including deaths). It may happen more in patients who are taking certain other medicines or who have had certain stomach or intestinal diseases.

Possible effects on the skin

Some patients taking Tarceva have developed serious skin conditions. Some patients have died from these conditions.

Possible effects on the eye

Some patients taking Tarceva have developed eye irritation and damage to the cornea. The cornea is the clear part of the eyeball that covers the colored part of the eye and the pupil. Other eye problems such as abnormal eyelash growth, dry eyes, or changes in eyesight have also been reported. Patients should tell their HCP about eye problems that get worse, including eye pain.

When to call your HCP

Call your HCP right away if you have these signs or symptoms:

• New or worsening skin rash
• Serious or ongoing diarrhea, nausea, loss of appetite, or vomiting
• New or worsening shortness of breath or cough
• Eye irritation

Before you start taking Tarceva

Some patients taking Tarceva have experienced difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding. Patients taking blood thinners (Coumadin^®, warfarin or other coumarin-derivatives) should be monitored regularly.

Taking other medicines and herbal supplements with Tarceva

Certain medicines and herbal supplements can affect how Tarceva works in the body. It is important that you tell your HCP about all of the medicines and herbal supplements you are taking. DO NOT start taking any new medicines or herbal supplements before talking with your HCP. Tarceva may also affect other medications you are taking.
In addition, grapefruit and grapefruit juice have an effect on how Tarceva works. DO NOT eat grapefruit or drink grapefruit juice while on treatment with Tarceva, except under the care of your HCP.
.

Common side effects of Tarceva

The most common side effects in patients who took Tarceva were generally mild to moderate rash and diarrhea. You may also have other changes in your skin.
The rash from Tarceva therapy may appear on your upper body or face. Typically rash occurs within 8 days of starting treatment, but it may occur any time during treatment with Tarceva.
The rash is not an allergic reaction. It may look like acne or dry skin. It is not acne. Talk to your HCP if a rash occurs.
Typically, diarrhea may develop within 12 days of starting Tarceva.
Hair and nail changes have been seen with Tarceva.

Not so good

Unfortunately, mom's scan results from the crizotinib showed that the medicine did not work at all. It had zero effect on the cancer and the tumors have grown 2-3 times the size. We are all so upset from this news because we all believed that this miracle drug would work. We have another appointment on tuesday to discuss new treatment options and clinical trials. Whatever we decide is going to be labeled as third line treatment. The clinical trials we have so far been told of are stage 1 clinical trials which means that they are completely new and have not been tried yet. If she decides to do a clinical trial the next one doesn't start for 5 weeks. This means she cannot be on any other treatment during that waiting "washout" period. Even then, I don't know if she will get in the trial because she is on a waiting list and then when the time comes they run tests to see if she is even eligible.

The other choice is to just start taking either Tarceva or Taxol. I will post info about both.

Mom, is extremely positive and so incredibly strong. We must all continue to pray because God can heal her. I believe it is his will and that this is another bump in the road.

Psalm 41:3
The LORD sustains them on their sickbed and restores them from their bed of illness.

Let us pray:
 
Dear Lord of Mercy and Father of Comfort,

You are the One I turn to for help in moments of weakness and times of need. I ask you to be with your servant, Cindy Hudson, in this illness. Psalm 107:20 says that you send out your Word and heal. So then, please send your healing Word to your servant, Cindy Hudson. In the name of Jesus, drive out all infirmity and sickness from her body.
Dear Lord, I ask you to turn this weakness into strength, suffering into compassion, sorrow into joy, and pain into comfort for others. May your servant trust in your goodness and hope in your faithfulness, even in the middle of this suffering. Let her be filled with patience and joy in your presence as she waits for your healing touch.
Please restore your servant, Cindy Hudson, to full health, dear Father. Remove all fear and doubt from her heart by the power of your Holy Spirit, and may you, Lord, be glorified through her life.
As you heal and renew your servant, Lord, may she bless and praise you.
All of this I pray in the name of Jesus Christ.
Amen.

Cindy had a girls weekend! Very cool!

So mom has been taking the Crizotinib targeted therapy drug for about 2 weeks and she was done with her last (round 6) intravenous chemo therapy of Avastin, Alimta, and Carboplatin combination about a month ago now.  She was feeling pretty bad after round 6, but it wasn't as bad as what I hear from other survivors who had very difficult chemo treatments. She still has her hair, she has back pain, her blood pressure has elevated, and she has been really tired and worn out. All this aside, she has been looking like she feels better and she does have a lot more energy. We will get the results of how the targeted therapy drug crizotinib is doing in about 2 and half weeks. Just keep praying that it is working! She is strong and continues the good fight!!!

Okay, so now that I've written all that I can tell you all that mom had a wonderful weekend with girlfriends. They took her out for some window shopping, people watching, awesome lunch and dinner, and even took in a show!! Mom said she felt like she had walked 10 miles and it shows that she is very happy to have had that energy! She had a great weekend and is in a really good mood. She is rather tired today though. So I made her some chicken pot pie. It was good. I am just really glad that she had such a great time with her friends!!!

Next week she will be leaving to visit Michael, Annie, and her grandchildren. I am soooo happy that she has this opportunity to go visit. It has been really difficult for her emotionally not see or be around her youngest son, his wife and grandchildren. The boys, William and Charlie are 3 and almost 5, are such a joy and she loves doting on them. I am just so happy that she will be spending Thanksgiving with them! We all have so much to be thankful for and we thank all of you for your continued support!
God Bless!

More info on the Avastin chemo drug-This is the news release from the FDA

The FDA results from the clinical trials are a little different from the company website info, but here is the press release info from the FDA to shed a little more light on the chemo drug Avastin. Remember that they removed the drug for its complications in regards to breast cancer. My mom has Non Small Cell Lung cancer (NSCL), and this drug is still being used in regards to that. She has finished the 6 rounds of chemo and is now using a different type of chemo. It is pill form called crizotinib and it is used for targeted therapy. Mom had positive results from the genetic marker testing. Info is posted on this blog. She did have some of the side effects from the Avastin that are listed in this press release during the chemo and we will have to wait and see how these symptoms will change after being done with the 6 rounds of chemo and the change to this new targeted therapy drug.

-Vanessa

 

FDA Commissioner announces Avastin decision
Drug not shown to be safe and effective in breast cancer patients

FDA Commissioner Margaret A. Hamburg, M.D., said today she is revoking the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).

“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use,” Dr. Hamburg said. “After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”

Avastin’s risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines.

Today’s decision, outlined in Dr Hamburg’s 69-page opinion, involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from Avastin’s product labeling.

Dr. Hamburg’s decision is based on an extensive record, which includes thousands of pages submitted to a public docket, data from several clinical trials and the record from a two-day hearing held in June, 2011.

Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. The accelerated approval program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. If the clinical trials do not justify the continued approval of the drug or a specific drug indication, the agency may revoke its approval. In this case, the accelerated approval was based on promising results from one study that suggested that the drug could provide a meaningful increase in the amount of time from when treatment is started until the tumor grows or the death of the patient.

After the accelerated approval of Avastin for breast cancer, the drug’s sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug.

FDA’s Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.

Genentech did not agree with the Center’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center’s withdrawal proposal, with a decision to be made by the Commissioner. That two-day hearing, which took place June 28-29, 2011, included recommendations from the FDA's Oncologic Drugs Advisory Committee (ODAC), voting 6-0 in favor of withdrawing approval of Avastin’s breast cancer indication. After the hearing, the public docket remained open until Aug. 4, 2011. (In an earlier meeting of the ODAC, that committee had voted 12-1 in favor of the removal of the breast cancer indication from the Avastin label).

“FDA is committed to working with sponsors to bring promising cancer drugs to market as quickly as possible using tools like accelerated approval,” Dr. Hamburg said. “I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug.”

For more information:

Avastin Decision¹

FY2011 Innovative Drug Approvals²

RSS Feed for FDA News Releases³ [what is RSS?⁴]

News about Avastin- Mom took the Avastin for the 6 rounds of chemo

The FDA has recalled Avastin in its use for metastatic breast cancer. It is still used for non small cell lung cancer in combination with carboplatin. It looks like the biggest worry with Avastin, in its use on nscl cancer, is the low white cell count. I'm glad that mom made it through the chemo and she seems to be doing well on the crizontinib. We won't know until next month when we get more scans done and see whats going on inside. She still has pain in her back, but she is looking great and looks like she is feeling better. She still gets worn out, but she recovers fast.

Friday, Nov 18, 2011

FDA Commissioner Announces Final Decision on Avastin for Metastatic Breast Cancer

South San Francisco, Calif. -- November 18, 2011 -- U.S. Food and Drug Administration (FDA) Commissioner revokes approval of Avastin for treatment of metastatic breast cancer (mBC) in the United States This action concludes the FDA's review of Avastin's use for mBC This decision does not impact Avastin's approved uses for other cancer types in the United States or other countries This decision also does not impact the approval of Avastin for mBC in more than 80 other countries Roche will start a new trial of Avastin plus paclitaxel in mBC Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the FDA Commissioner is revoking the approval of Avastin® (bevacizumab) for the treatment of mBC in the United States. "We are disappointed with the outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Despite today's action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin." Information for Doctors and Patients Genentech will issue a letter to healthcare providers and will also provide them with a letter to distribute to their patients. Both letters will be made available on Genentech's website. Patients with questions or concerns about insurance coverage or doctors with questions about reimbursement can call Genentech's Access Solutions Group at (866) 4 ACCESS, our team of specialists may be able to help. Doctors with questions about Avastin can call Genentech's Medical Communications group at (800) 821-8590. The FDA's action does not impact ongoing trials with Avastin in breast cancer. For more information, please call Genentech's Trial Information Support Line at (888) 662-6728 or visit clinicaltrials.gov. About Avastin Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called VEGF that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize). For more information about angiogenesis, visit http://www.gene.com. Avastin is approved for first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy, first-line treatment of unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small cell lung cancer in combination with carboplatin and paclitaxel, and metastatic renal cell carcinoma in combination with interferon alfa. BOXED WARNINGS and Additional Important Safety Information People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including: Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, this event occurred in more people who received Avastin than in the comparison group (2.4 percent to 0.3 percent). In some cases, GI perforation resulted in fatality. Avastin therapy should be permanently stopped if GI perforation occurs. Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. In a controlled clinical trial, in patients with metastatic colorectal cancer who had surgery during the course of treatment, the incidence of wound healing complications, including serious and fatal complications, was 15 percent for patients who received Avastin and four percent for patients who did not receive Avastin. Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of wound healing problems following surgery has not been determined. Treatment with Avastin should be stopped at least 28 days before voluntary surgery and in people with wound healing problems following surgery that require medical treatment. Treatment with Avastin should be stopped in patients with slow or incomplete wound healing. Severe bleeding: Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy. Across cancer types, 1.2 percent to 4.6 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs. In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.4 percent of people. Too much protein in the urine that led to kidney problems was seen in less than one percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in five percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than three percent of people, and severe reactions occurred in 0.2 percent of people. Avastin could cause a woman?s ovaries to stop working and may impair her ability to have children. Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects. Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin. Women should be advised to discontinue nursing or discontinue treatment with Avastin, taking into account the importance of Avastin to the mother. First-line Metastatic Colorectal Cancer In the first-line metastatic colorectal cancer trial, the most common severe to life-threatening side effects that increased by two percent or more in people who received Avastin plus IFL chemotherapy vs. IFL alone were weakness (10 percent vs. 7 percent), abdominal pain (8 percent vs. 5 percent), pain (8 percent vs. 5 percent), high blood pressure (12 percent vs. 2 percent), blood clots in the veins of the body (9 percent vs. 5 percent), blood clots inside the abdomen (3 percent vs. 1 percent), a brief loss of consciousness (3 percent vs. 1 percent), diarrhea (34 percent vs. 25 percent), constipation (4 percent vs. 2 percent), reduced white blood cell counts (37 percent vs. 31 percent), and reduced white blood cell counts that may increase the chance of infection (21 percent vs. 14 percent). Second-line Metastatic Colorectal Cancer In the second-line metastatic colorectal cancer trial, the most common severe to life-threatening and fatal side effects that increased by two percent or more in people who received Avastin plus FOLFOX4 chemotherapy vs. FOLFOX4 alone were diarrhea (18 percent vs. 13 percent), nausea (12 percent vs. 5 percent), vomiting (11 percent vs. 4 percent), dehydration (10 percent vs. 5 percent), blockage of the bowel (4 percent vs. 1 percent), numbness and tingling in fingers and toes (17 percent vs. 9 percent), nervous system disturbances (5 percent vs. 3 percent), tiredness (19 percent vs. 13 percent), abdominal pain (8 percent vs. 5 percent), headache (3 percent vs. 0 percent), high blood pressure (9 percent vs. 2 percent), and severe bleeding (5 percent vs. 1 percent). First-line Advanced Non-Squamous Non-Small Cell Lung Cancer In the non-small cell lung cancer trial, the most common life-threatening to fatal side effects that increased by two percent or more in people who received Avastin vs. those in the comparison group were reduced white blood cell counts (27 percent vs. 17 percent), tiredness (16 percent vs. 13 percent), high blood pressure (8 percent vs. 0.7 percent), infection without reduced white blood cell counts (7 percent vs. 3 percent), blood clots in the veins of the body (5 percent vs. 3 percent), fever with reduced white blood cell counts (5 percent vs. 2 percent), inflammation of the lungs (5 percent vs. 3 percent), infection with severe or life-threatening reduced white blood cell counts (4 percent vs. 2 percent), low sodium levels in the blood that could lead to seizure or coma (4 percent vs. 1 percent), headache (3 percent vs. 1 percent), and too much protein in the urine (3 percent vs. 0 percent). Metastatic Kidney Cancer In the metastatic kidney cancer trial, the most common severe to fatal side effects that increased by two percent or more in people who received Avastin vs. those in the comparison group included tiredness (13 percent vs. 8 percent), weakness (10 percent vs. 7 percent), too much protein in the urine (7 percent vs. 0 percent), high blood pressure (6 percent vs. 1 percent), and severe bleeding (3 percent vs. 0.3 percent). For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com. About Genentech Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. ###

FYI on clinical studies and survival rate. Believe she is healing!

The Lancet Oncology, Volume 12, Issue 11, Pages 1004 - 1012, October 2011

<Previous Article|Next Article>

doi:10.1016/S1470-2045(11)70232-7Cite or Link Using DOI

Published Online: 19 September 2011

Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis

Original Text

Dr Alice T Shaw MD a , Beow Y Yeap ScD a, Benjamin J Solomon MD b, Gregory J Riely MD c, Justin Gainor MD a, Jeffrey A Engelman MD a, Geoffrey I Shapiro MD d, Daniel B Costa MD e, Sai-Hong I Ou MD f, Mohit Butaney BS d, Prof Ravi Salgia MD g, Robert G Maki MD c, Prof Marileila Varella-Garcia PhD h, Robert C Doebele MD h, Prof Yung-Jue Bang MD i, Kimary Kulig PhD j, Paulina Selaru MSPH j, Yiyun Tang PhD j, Keith D Wilner PhD j, Eunice L Kwak MD a, Jeffrey W Clark MD a, A John Iafrate MD k, D Ross Camidge MD h

Summary

Background

ALK gene rearrangement defines a new molecular subtype of non-small-cell lung cancer (NSCLC). In a recent phase 1 clinical trial, the ALK tyrosine-kinase inhibitor (TKI) crizotinib showed marked antitumour activity in patients with advanced, ALK-positive NSCLC. To assess whether crizotinib affects overall survival in these patients, we did a retrospective study comparing survival outcomes in crizotinib-treated patients in the trial and crizotinib-naive controls screened during the same time period.

Methods

We examined overall survival in patients with advanced, ALK-positive NSCLC who enrolled in the phase 1 clinical trial of crizotinib, focusing on the cohort of 82 patients who had enrolled through Feb 10, 2010. For comparators, we identified 36 ALK-positive patients from trial sites who were not given crizotinib (ALK-positive controls), 67 patients without ALK rearrangement but positive for EGFR mutation, and 253 wild-type patients lacking either ALK rearrangement or EGFR mutation. To assess differences in overall survival, we assessed subsets of clinically comparable ALK-positive and ALK-negative patients.

Findings

Among 82 ALK-positive patients who were given crizotinib, median overall survival from initiation of crizotinib has not been reached (95% CI 17 months to not reached); 1-year overall survival was 74% (95% CI 63—82), and 2-year overall survival was 54% (40—66). Overall survival did not differ based on age, sex, smoking history, or ethnic origin. Survival in 30 ALK-positive patients who were given crizotinib in the second-line or third-line setting was significantly longer than in 23 ALK-positive controls given any second-line therapy (median overall survival not reached [95% CI 14 months to not reached] vs 6 months [4—17], 1-year overall survival 70% [95% CI 50—83] vs 44% [23—64], and 2-year overall survival 55% [33—72] vs 12% [2—30]; hazard ratio 0·36, 95% CI 0·17—0·75; p=0·004). Survival in 56 crizotinib-treated, ALK-positive patients was similar to that in 63 ALK-negative, EGFR-positive patients given EGFR TKI therapy (median overall survival not reached [95% CI 17 months to not reached] vs 24 months [15—34], 1-year overall survival 71% [95% CI 58—81] vs 74% [61—83], and 2-year overall survival 57% [40—71] vs 52% [38—65]; p=0·786), whereas survival in 36 crizotinib-naive, ALK-positive controls was similar to that in 253 wild-type controls (median overall survival 20 months [95% CI 13—26] vs 15 months [13—17]; p=0·244).

Interpretation

In patients with advanced, ALK-positive NSCLC, crizotinib therapy is associated with improved survival compared with that of crizotinib-naive controls. ALK rearrangement is not a favourable prognostic factor in advanced NSCLC.

Funding

Pfizer Inc, V Foundation for Cancer Research.

Crizotinib Approval For Lung Cancer Shows Our Miracles Aren't Getting Less Expensive

<a href="http://www.cancer.org/AboutUs/DrLensBlog/post/2011/08/30/Crizotinib-Approval-For-Lung-Cancer-Shows-Our-Miracles-Arent-Getting-Less-Expensive.aspx#.TriwwJFLLMs.blogger">Crizotinib Approval For Lung Cancer Shows Our Miracles Aren't Getting Less Expensive</a>Interesting article. The expense is overwhelming. Its crazy to see that mom's new targeted drug therapy for the pills alone costs $115,000 a year. We will do everything we can to continue to get her the best treatment and heal her. She will become No Evidence of Disease!!! It is God's will. On that note, I think we will need to organize a fundraiser for next year in the spring time while the weather is nice. One comment at the bottom of this article (posted before) tells of how the pills worked great for one's mom who was in the clinical trials. This is great news!
-Vanessa

An excerpt from someone who's mother has taken crizotinib

"But when my mother was on Crizotinib, she had ZERO side effects. Yes, ZERO. Maybe during the first week she had some nausea/vomiting which can be taken care often easily by drugs or by eating a little food with crizotinib, but after first week it was gone. She had no side effects. I'd imagine some people had other side effects, but none even anywhere close to chemo. Could you name a single chemo drug for which there are people who claim zero side effects?

Not to mention that this drug can lead to better drugs in future.?

kitty

Mom's update. No results just yet on new drug. Give it some time and keep praying.

Well, mom has started the new drug and has been on it for about a week. She is not noticing improvement yet, but keep praying. She will get better!!! Before she started taking the medicine and after round 6 of chemo, she has been suffering from some pretty severe pain in the upper lung area of her back (behind the scapula). The pain is still the same so far. She is still working as much as she can and she gets wiped out by the end of the day. She is suffering from nausea (actually threw up today), but that is a big side effect of the new drug too. Hopefully she will start feeling better soon. Keep her in your prayers and thank you all.

More information on mom's new drug information. The previous posts are more detailed on the drug she is now taking. Please read them all to learn what she is going through.

New Lung Cancer Pill Highlights Improved Way of Treating Patients By ENJOLI FRANCIS and RICHARD BESSER Aug. 30, 2011 —

go.com

A new drug to combat a certain type of lung cancer is being hailed today as an "amazing development" by medical experts.

The drug crizotinib (Xalkori), manufactured by Pfizer and approved last week by the Food and Drug Administration, is intended for a small number of patients.

The twice-daily capsules are meant for patients with non-small cell lung cancer who have a unique gene known as an abnormal anaplastic lymphoma kinase(ALK). An ALK gene causes cancer growth and development.

Pfizer held a panel today to discuss the implications of the new drug.

"What we've seen from studies to date is that this pill does have significant activity," said Dr. Alice Shaw, a thoracic oncologist at Massachusetts General Hospital Cancer Center, who took part in crizotinib studies. "For about 60 percent of patients, they will have a significant shrinkage in their tumors and what the preliminary studies have also shown is that the median or average duration of response is on the order of 10 months."

Lung Cancer Drug Blocks Proteins

Crizotinib works by blocking the proteins produced by the ALK gene. The FDA also approved a diagnostic test by Abbott Laboratories that screens for the gene. Patients found to have the gene would be able to be prescribed the pill, although chemotherapy and radiation therapies would remain options.

The most common side effects, according to Medpage Today, reported in patients taking crizotinib were vision disorders, nausea and edema.

About 187,000, or 85 percent of the 220,000 lung cancer cases diagnosed yearly, are non-small cell lung cancer. Of those cases, less than 7 percent have the ALK gene.

Dr. David Carbone, a lung cancer specialist at Vanderbilt University, one of the sites that tested the drug, told The Associated Press that for those patients, crizotinib made a huge difference. "It's pretty exciting," he said.

"For many patients, this drug has been a lifesaver," Massachusetts General's Shaw told ABC News. "For many patients, they experienced a very immediate and significant relief in their symptoms, sometimes within the first week."

Dr. Roy S. Herbst, chief of medical oncology at Yale Cancer Center, said that crizotinib's FDA approval was a "pivotal milestone" in lung cancer treatment.

"It's another example of how we are using molecular medicine to effectively treat a subset of cancer patients," Herbst told ABC News via email.

More on Crizotinib

Pfizer Inc.'s just-approved drug Xalkori, the first new medicine in more than six years for deadly lung cancer, proves the value of precisely targeting rare diseases linked to gene variants, cancer specialists and Pfizer executives said Tuesday.
The drug was approved Friday in the U.S. along with a companion diagnostic test for just a small subset of lung cancer patients. It epitomizes drugmakers' new strategy of developing very expensive but effective medicines for relatively few patients to replace the blockbusters for the masses now getting competition from generic drugs.
It's also in the vanguard of long-awaited personalized medicine, in which doctors identify patients with gene changes or variations that fuel their disease and then try to match them with new medicines that specifically target those genes.
"This is a paradigm shift," Dr. Paul A. Bunn Jr., a University of Colorado professor and cancer researcher involved in testing Xalkori, told journalists during a conference call hosted by Pfizer. "It used to be that everybody with cancer was treated the same," with surgery and chemotherapy.
Xalkori, a pill with relatively minor side effects compared to the hair loss and nausea that chemotherapy can cause, was approved for the roughly 4 percent of patients with advanced nonsmall cell lung cancer who have what's called the ALK fusion gene.
When ALK, short for anaplastic lymphoma kinase, and another gene on the same chromosome rearrange their positions and fuse together, the ALK gene stays on constantly, fueling cancer cell growth. Xalkori works by blocking the kinase enzyme, key to that process.
About 6,000 Americans a year develop this cancer, Pfizer said. Those patients, called ALK positive, now can be identified with a $250 molecular diagnostic test developed by Pfizer's partner, Abbott Molecular Oncology. The test was also approved Friday.
"You're going to be sparing individuals side effects (and) the waste of resources, time and drug that really isn't going to help them," Dr. Mark Kris, head of the thoracic oncology service at Memorial Sloan-Kettering Cancer Center in New York, said during the call.
Normally doctors choose among different chemotherpay regimens for each patient, and they may not pick an effective one.
In Pfizer-funded early and midstage studies that led to Xalkori's approval, tumors disappeared, shrank or stopped growing in just over half of patients for nearly two years on average. Research to determine overall survival is ongoing.
By comparison, nonsmall cell lung cancer – about 85 percent of cancer cases – is tough to treat and kills nearly 95 percent of patients within five years. Lung cancer is the top killer among cancers worldwide.
Xalkori, known chemically as crizotinib, costs about $9,600 a month and is taken until it stops fighting tumors, at which point patients likely would be put on older chemo drugs they hadn't taken yet. Pfizer has started a Xalkori patient assistance program with a maximum $100 monthly copayment for insured patients meeting certain financial limits. Insurers are expected to cover the drug for ALK-positive patients.
Jeff Wigbels, an investment bank portflio manager treated in one of the drug studies, said when he started taking it, he couldn't eat because cancer had spread to his throat. Within a week he could eat again and soon scans of his lung and throat no longer showed tumors.
"It was just an amazing experience," he said.
Another patient, Richard Heimler, a former nonprofit executive, said he had one cancerous lung removed seven years ago and repeatedly had new tumors surgically removed from his brain and the other lung, along with chemotherapy. He began taking Xalkori 15 months ago and still takes a pill twice a day.
"My tumors have either disappeared, shrunk or are stable," said Heimler, and he's functioning well again.
Pfizer is currently running two late-stage studies that compare Xalkori to different chemotherapy treatments that have been the standard of care. It's unusual to get approval before completing such large, late-stage studies. Xalkori was approved remarkably quickly, just four years after Japanese researchers reported they had identified the ALK gene variation.
Pfizer is awaiting approval from regulators in the European Union, Switzerland, Japan and Korea, and also is testing crizotinib against other types of cancer.
Pfizer said 3 percent to 5 percent of patients with nonsmall cell lung cancer have the ALK gene fusion. But one research group presented data at a recent cancer conference showing 8 percent of those patients have it.
Pfizer needs some big sellers because its $10.7 billion-a-year cholesterol fighter, Lipitor, the world's top-selling drug, loses U.S. patent protection on Nov. 30. That starts an unprecedented wave of much-cheaper generic versions of many drugs taken daily by millions.
Geno Germano, head of Pfizer's specialty care and oncology business, said Xalkori's development shows Pfizer's core research operation has bounced back.
After successes including Lipitor, antidepressant Zoloft and impotence pill Viagra in the 1990s, Pfizer's in-house scientists have had a string of high-profile drugs fail in patient testing in recent years. That's forced the company to acquire many new drugs through acquisitions and licensing deals.

Information on Mom's positive test for the ALK gene mutation of her cancer

This is great nes news- the generic name is Crizotinib, but you will see it listed as Xalkori. Anyway, it is a very promising drup and people have become no evidence of disease after taking this form of targeted therapy!!! Keep praying!!!   -Nessa

FDA NEWS RELEASE

For Immediate Release: Aug. 26, 2011
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Xalkori with companion diagnostic for a type of late-stage lung cancer
Second targeted therapy approved with a test this year

The U.S. Food and Drug Administration today approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.

Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit. It is the second such targeted therapy approved by the FDA this year.

This ALK gene abnormality causes cancer development and growth. About 1 percent to 7 percent of those with NSCLC have the ALK gene abnormality. Patients with this form of lung cancer are typically non-smokers. Xalkori works by blocking certain proteins called kinases, including the protein produced by the abnormal ALK gene. Xalkori is a pill taken twice a day as a single-agent treatment.

“The approval of Xalkori with a specific test allows the selection of patients who are more likely to respond to the drug” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Targeted therapies such as Xalkori are important options for treating patients with this disease and may ultimately result in fewer side effects.”

Xalkori’s safety and effectiveness were established in two multi-center, single-arm studies enrolling a total of 255 patients with late-stage ALK-positive NSCLC. A sample of a patient’s lung cancer tissue was collected and tested for the ALK gene abnormality prior to study enrollment. The studies were designed to measure objective response rate, the percentage of patients who experienced complete or partial cancer shrinkage. Most patients in the studies had received prior chemotherapy.

In one study, the objective response rate was 50 percent with a median response duration of 42 weeks. In another, the objective response rate was 61 percent with a median response duration of 48 weeks.

The FDA based its approval of the Vysis ALK Break Apart FISH Probe Kit on data from one of the studies.

Xalkori was reviewed under the FDA’s priority review program, which provides for an expedited six-month review of drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists.

Xalkori is being approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients. The program is designed to provide patients with earlier access to promising new drugs, followed by further studies to confirm the drug’s clinical benefit.

Xalkori and the companion Vysis ALK Break Apart FISH Probe Kit were approved ahead of the drug’s Sept. 30, 2011, FDA review goal date and the companion diagnostics’ Sept. 28, 2011, review goal date.

“The trend in oncology research continues towards targeted therapies,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health. “This test is an example of the important role companion diagnostics play in determining that the safest and most effective treatments are promptly delivered to patients living with serious and life-threatening diseases.”

The most common side effects reported in patients receiving Xalkori included vision disorders, nausea, diarrhea, vomiting, swelling (edema), and constipation. Vision disorders included visual impairment, flashes of light, blurred vision, floaters, double vision, sensitivity to light, and visual field defects. Xalkori use has also been associated with inflammation of the lung tissue (pneumonitis), which can be life-threatening. Patients with treatment-related pneumonitis should permanently stop treatment with Xalkori. The drug should not be used in pregnant women.

In July 2011, FDA issued a draft guidance industry on the agency’s policy for reviewing a companion diagnostic and the corresponding drug therapy. The guidance is currently available for public comment.

Xalkori is marketed by New York City-based Pfizer. The Vysis ALK Break Apart FISH Probe Kit is marketed by Abbott Molecular Inc. of Des Plaines, Ill.

For more information:

FDA: Office of Oncology Drug Products¹

FDA: Office of In Vitro Diagnostics²

FDA: Draft Guidance – In Vitro Companion Diagnostic Devices³

FDA: Approved Drugs: Questions and Answers⁴

NCI: Non-small cell lung cancer ⁵***** 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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RSS Feed for FDA News Releases⁶ [what is RSS?⁷]

-Vanessa

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Lung Cancer Pill Holds Promise for those pass genetic testing-ALK Gene

Lung Cancer Pill Holds Promise For Those Who Pass Test (Crizotinib-Xalkori)

by Scott Hensley

08:11 am

August 30, 2011

From Pfizer, a drugmaker known best for medicines to treat millions, there is now a twice-a-day pill to treat lung cancer that will be prescribed for only a few thousand people each year.

The Food and Drug Administration approved Pfizer's Xalkori to treat patients with a particular form of non-small cell lung cancer, one that is marked by a genetic variation called ALK.
Only people with tumors that test positive for ALK — about 3 to 5 percent of NSCLC patients, or around 6,500 to 11,000 U.S. patients a year — are candidates for the treatment. By comparison, last year more than 45 million prescriptions were dispensed for Lipitor, the cholesterol-fighter that is Pfizer's biggest seller.

The FDA approved the pill in combination with a genetic test to detect the ALK variation to figure out who has the best chance of responding to the medicine.
The new, highly targeted cancer pill won't come cheap at about $9,600 a month. But the benefits for those with the ALK-positive cancers appear to be substantial. Half or more of patients in the studies cited in the FDA approval responded well to treatment with Xalkori. Their tumors shrank or disappeared.

But there are no definitive data so far on whether the drug extends life, though that's expected to be the case. The FDA approved the drug quickly, under a priority review approach reserved for drugs that have special promise. Pfizer has to perform more studies of the drug to confirm the agency's assessment of Xalkori.

Common side effects from Xalkori include vision problems, nausea and diarrhea. More rarely, in less than 2 percent of cases, patients experienced life-threatening inflammation of the lungs.
One high-profile patient who took Xalkori in clinical trials is former Microsoft engineer Andy Hill, a state senator in Washington. Diagnosed with NSCLC in early 2009, he started taking the pill in October of that year. Since Feb. 2010, he's shown no signs of lung cancer. "It's pretty miraculous," he told the Redmond Reporter. "I am doing things I never thought I would ever be able to do again."
For more on Hill's case and how cancer patients can make the best use of the Internet and medical professionals in making treatment decisions, watch the video below of Dr. Jack West, a lung cancer specialist at Seattle's Swedish Medical Center. (Hat tip on video to Sally Church at Icarus Consulting.)

-Vanessa

So far this week

Please read the last post for the latest update with Dr's office from last thursday. As far as this week goes, mom isn't feeling too well. She has fluid building up again and will have to go get it drained (thoracentesis) again possibly tomorrow. She is in pain on the right side of her chest. As the fluid builds in the pleural space outside the lung it begins to crush the lung.

We have not been able to get the new medicine Crizotinib yet because the pharmacy did not have it and has to order it. She is checking with them everyday on when it will arrive so that she may go get it. We don't know the exact cost of it yet either, but without insurance it is somewhere around and close to $10,000 for a one month -30 day supply. That is what we were told by the doctor. Even though the medical expenses are astronomical, the fact that mom has been receptive to the chemo (for the most part) thus far and the fact that she is positive for this ALK gene, the expectations are high for the positive results from the crizotinib. It is a pill with minimal side effects. Please God let this work on her and make her no evidence of disease!!!! We are all hopeful and praying!!

Thank you all. If you have any questions or concerns please feel free to ask and post them. Thanks.

-Vanessa

The Bad, the good news, and the unknown.

Well, the CT scan results were good and bad, but more bad than good. However, now we have an opportunity for great. I will explain, but I wanted everyone to know that there is a possible, very positive outcome in all this first.

So, we were sitting in the room and the Physician Assistant came in looking VERY grim and started reading all the results of the scan. He said there’s good and bad. He said: the bad is you have a tumor next to your heart and it is growing minimally. The pleural wall thickening has increased also. The good is that the tumors in your right lung have decreased in size. You won’t get any more chemo because Six rounds is the limit for you and it doesn’t look like it is working well enough anymore. The tumor and thickening that have grown may be a different mutation of the cancer or a different type. The cancer travels through blood and that is how it metastasizes (moves around in the body and attaches itself there).

It was very traumatic and difficult to hear. So, I immediately asked the PA about the genetic testing that was done on the fluid in her lungs (that had the cancer cells in it- the testing is done for the purpose of targeted therapy) <Side Note: I have asked every meeting with PA since July when it was done. Results came in August when they switched doctors on us and then the results were ‘lost’, but at the last appointment I asked again and he said he would personally find them>, the results were in the chart and it found that she was positive for the ALK Gene. However, it was a partial mutation. I don’t know what that means yet because I don’t have a copy of the results. I will ask for them. Anyway, this is good news. Once the PA and Doctor saw the  results of this they became so excited for my moms future and what this means. They were so giddy and practically dancing over finding out that she had this ALK gene. The FDA recently pushed to pass a drug called Crizotiib that is targeted for this ALK gene. The difference means that where Chemo works 30% this pill drug with minimal side effects works 70% results. Only 5% of lung cancers have this ALK gene mutation. It is incredibly rare.This is amazing that she has it. It is unknown territory, but this is great. It is positive. It is good news. We now have another chance at beating this disease!! She can heal with our prayers!! Everyone must believe this and believe in God's will and understanding.

It is so easy to fall into a dark place of the hopelessness and helplessness that is felt when you are dealing with cancer. We all must stay positive and remember our faith and believe in God's healing power. Pray with me.... us.....

I pray that she will become No Evidence of Disease (NED). God please continue to heal her physically and emotionally. Be with her always and let her feel your strength and goodness. Help her to know that she is not alone and that we all support her. Please God Bless her soul, forgive her for any wrong and misgivings, absolve her of all her sins. Please lord be with her. She is so good and amazing and we need her presence in our lives. Please Lord be with us and hear our prayers. Amen.

God, I ask you to heal her. I love her so much and I am not ready for any more bad news. I know that is selfish of me, but I ask you to please heal her. She is one of your vessels and I appreciate that, but please let her be a learning experience and heal her. Thank you for all that you have done. I know you are with us and I appreciate your kindness and your help in everything that you give us. Thank you. Amen.

-Vanessa

Nervous about CT Scans tomorrow

Well, tomorrow Mom gets more CT scans at 3pm. Mom is a little nervous and anxious. It hard waiting to get the results. We just pray that the scans show the tumors gone! I know God is healing her and please lord, please don't show anything on those and please do show that the tumors are gone. Amen.

We appreciate all of your prayers. Please continue to pray with us this week as we get the results on thursday. Thank you and God bless.

Realizing she is physically not up to her usual strength is tough this week

Mom, is okay but this week has been a little tough. She had her round six chemo treatment a week ago last Thursday and I think it actually wiped her out the most of all of them. She was definitely more fatigued and suffered from exhaustion longer this time. She was pretty much out of it last weekend and just rested. She told me that Tuesday was a really rough day for her and that the people in the child support court (basement of court house were extremely helpful to her). She is still going to work to help keep her mind off things and of course there are lots of bills to pay so she actually has to work. Anyway, she almost passed out from the nausea and effects of the chemo, but her friends and colleagues were there to help and she is extremely grateful. The rest of the week went alright, but by the time she got home at the end of the day she was exhausted. This weekend she has been picking up around the house and has been vacuuming and it is definitely harder for her physically as well as emotionally because she realizes that she is not as strong as she once was. It was very difficult, but she is stronger than she realizes too!!! Her physical strength will come back as well.

On tuesday we go for more CT scans and the Dr's appointment is next thursday. I will keep you informed on the results.

Thank you.