Komen to FDA: Don’t shut the door on Avastin yet
Acknowledging the FDA conducted a thorough investigation and made a hard decision to propose withdrawing marketing approval for Avastin for metastatic breast cancer, we still want another public hearing to be held. We sent a letter yesterday to the FDA encouraging the agency to hold a hearing to talk about the appeal made by Avastin’s maker, Genentech/Roche.
The FDA cited studies indicating Avastin did not affect overall survival of metastatic breast cancer patients and had significant side effects for many.
However, we also know that for some number of women, Avastin works and works well. We have heard from women who are gaining not just months, but years, with a high quality of life, from this treatment. We are concerned about the potential impact on women who are currently benefiting from Avastin if the FDA removes its approval for its use as a treatment for metastatic breast cancer. We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, and that their insurers will continue to pay for it.
We also want Genentech/Roche to keep making the drug available to women through its patient support programs, consider an expanded access program and continue research on a biomarker for Avastin to determine which women will benefit from the drug.
The full text of the letter is available here