Wednesday, June 29, 2011

Today's FDA Avastin Decision

There's a lot of news out there about the FDA's 6 to 0 vote today recommending that Avastin not gain full approval for treating women with metastatic breast cancer. This case has been watched closely by both drug companies and cancer patient advocate groups. The final decision for withdrawing full approval rests with the FDA Commissioner, Margaret Hamberg. According to one news source, that decision will be rendered later this summer.

I've followed this issue closely. I'm not going to comment on the accelerated approval process granted by the FDA which allowed on label use of this drug sooner than later. With some fear of upsetting people who sided against the FDA, based on what I've read and after careful consideration, the FDA panel is making a sound recommendation.

I base this on the assumption, which I believe to be true, that the NCCN (National Comprehensive Cancer Network) Compendium will continue to list Avastin as a treatment option for breast cancer. This compendium is used by many insurance companies and Medicare to determine which treatments will be reimbursed. The panel's recommendation and ultimate decision to remove the breast cancer approval will not prevent doctors from prescribing Avastin to their breast cancer patients. In addition, Avastin is a serious drug with potentially deadly side-effects (internal bleeding). Unfortunately for patients, Genentech, and our hope for a cure, Avastin showed only marginal benefit in two recent studies. There are many, myself included, that for some people Avastin is the answer and our medical community is hard at work to find the bio-markers which show which patients have the greatest chance of success without endangering women who will not benefit.

Today's recommendation is a win for patients, doctors, and the FDA. Patients will continue to have access to this treatment regimen, insurance companies will continue to pay for the treatment, doctors will still be able to prescribe it to patients who they believe it will benefits, and the FDA is protecting the American people against unnecessary risks.

In closing, I credit my medical team who had the foresight to treat me with Avastin (in off-label use for head & neck cancer) with significantly prolonging my life although I can't prove that it was the Avastin that did the trick. I wish the two recent Avastin breast cancer studies on which the FDA panel based their recommendation had shown great benefit for breast cancer patients, but they didn't.

Lastly, I apologize to anyone I may offend for having sided with the FDA on this one. It is not about the money, it is not about death panels, it is not about Obama care; it is about the science.

Take care.

1 comment:

Alicia Kirk said...

My uncle has lung cancer with metastasis in the liver, lung and coxi, besides to the leg. This with morphine and many more medications.... Today also has spots under the purple pelvis! Does that mean that is hacerca the end? Anyone can help me of going forward until it reaches the death.