Posted by our Abigail Alliance friends at the Lung Cancer Alliance on their website 12-17-09
LUNG CANCER ALLIANCE DISAPPOINTED WITH
FOOD AND DRUG ADMINISTRATION COMMITTEE RECOMMENDATION
Panel Votes Against Approval of Tarceva® as Maintenance Drug
Washington, DC [December 17, 2009]— Yesterday, an advisory committee to the Food and Drug Administration voted against the approval of Tarceva® (erlotinib) as maintenance treatment for advanced lung cancer patients.
The Drug Evaluation and Research Oncologic Drugs Advisory Committee (ODAC), a panel of independent medical and scientific experts and patient representatives that reviews drug safety and efficacy data, voted 12-1 against the approval. The panel’s vote is not binding on the FDA which must reach a final decision by January 18, 2010.
At issue is whether Tarceva should be approved for first line maintenance monotherapy treatment for patients with locally advanced or metastatic non-small cell lung cancer and for those patients who have not progressed on first line treatments with a platinum based chemotherapy.
“We are very disappointed with this recommendation,” said Laurie Fenton Ambrose, Lung Cancer Alliance (LCA) President & CEO. “While we understand the importance of statistical analysis when evaluating drug approval, the Committee’s recommendation fails to appreciate the practical patient applications, especially with no safety concerns noted. The result is additional limitations on already limited options.”
Lung cancer is the leading cause of cancer death in the United States. It takes more lives than breast, prostate and colon cancers—combined. Over 70% of lung cancers are diagnosed at an advanced stage when curative surgery is not an option. Tarceva® is critically important to many lung cancer patients as it provides an option with limited side effects and portability.
“I was given two months to live when I was diagnosed almost five years ago. Tarceva® changed my life,” said Mike Stevens, four and a half year late stage lung cancer survivor and LCA-California Chair, in a statement read at the meeting. “During the nearly four years I was on Tarceva, I was able to travel with my wife for our 25th wedding anniversary, watch my daughter start college and my son turn 16. I truly owe my life and the quality of my life to Tarceva®.”
“We hope that FDA leadership will not follow the recommendations of ODAC and will approve Tarceva® in the maintenance setting so that lung cancer patients have another option that will help them live longer and enjoy a heightened quality of life,” concluded Fenton Ambrose.
To view LCA’s complete statement read at ODAC, click here.
As the only national non-profit organization dedicated exclusively to patient support and advocacy for those living with or at risk for lung cancer, Lung Cancer Alliance is committed to leading the movement to reverse decades of stigma and neglect by empowering those with or at risk for the disease, elevating awareness and changing health policy.
Over at Experimental Drug Therapies Blog there was some great discussion around the Abigail Alliance’s mission. When we caught wind of it, Frank stopped by and added his own thoughts. Click here to to read it all. Below are Frank’s comments:
This is great that there is such an excellent discussion going here on this blog. Let me add and clarify a few things from the extensive comments.
As regards safety, what the Abigail Alliance and the bill in Congress, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act S.3046 H.R.6270), are talking about are drugs and vaccines for cancer and other serious life-threatening illnesses that are showing significant efficacy in clinical trials. Also it is important to keep in mind that drugs and vaccines in clinical trials are very closely monitored for safety. Another important point is that the decision to take an investigational drug by a person who has run out of FDA approved options and cannot get into a clinical trial, should be the patient’s in consultation with their doctor.
Here is what is profound (from www.abigail-alliance.org):
“Every drug for cancer and other serious life-threatening illnesses that the Abigail Alliance has pushed for earlier access to in our eight-year history is now approved by the FDA! There is not one drug that we pushed for earlier access to that did not make it through the clinical trial process. Many lives could have been saved or extended, if there had been earlier access to these drugs!”
As of early 2009 the count is 16 drugs! EVEN the FDA’s own Science and Technology Board in their late 2007 report recommended there be a provisional approval mechanism for promising developmental drugs.
Speaking of the FDA Science and Technology Board, they and for a long time the Critical Path Initiative (www.c-path.org) have been pushing the FDA to use more modern scientific and statistical tools in clinical trial design, drug data, drug review, and approval. The ACCESS Act covers many early access issues, including jump starting the FDA using more modern tools.
By the FDA using more modern scientific and statistical tools, the use of placeboes would be greatly reduced. There are a significant number of patients who opt not to enroll in clinical trials, because they don’t want to take the risk of getting a placebo. Therefore the ACCESS Act would actually help speed up clinical trial enrollment.
One last note for now is that data outside a clinical trial can add to the knowledge about a new therapy.
Thank you all for your input.
Frank Burroughs, Abigail Alliance
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Thanks for joining us in the fight to provide better access to developmental drugs. We will be using this blog to discuss the latest in our battles with the FDA as well as highlight the work of others who share our goal of saving lives.