Anyone interested in the trials and tribulations of bringing a new cancer therapy to market, and keeping it there, is likely already aware of the fate of Genentech's Avastin. Last Friday, the FDA revoked its approval of the use of the drug to treat metastatic breast cancer, to the dismay of many patients and their advocates. The revocation was based on studies showing that the drug, which can have serious side effects, failed to help patients live longer.
FDA Commissioner Margaret Hamburg, MD, issued a 69-page document explaining her decision. Today David Kroll, author of the PLoS Blog Take as Directed, called my attention to the fact that the lengthy document includes a good Q&A about the issue to help patients and their physicians understand what the new ruling means to them. Topics include whether physicians can continue to prescribe the drug for metastatic breast cancer, how the FDA ensured that Avastin got a fair hearing, and whether it's possible that Avastin could again be approved at some point in the future for use in breast cancer patients.
You can read the full Q&A on Kroll's blog post, or find it in the opening pages of the FDA document