Avastin Approval Withdrawn
This is clearly today's big news about breast cancer. In some ways, the FDA's announcement yesterday that it is withdrawing its approval of Avastin as a treatment for advanced/metastatic/Stage IV breast cancer is anti-climactic. You will recall that an Advisory Panel made this recommendation several months ago. However, the formal announcement is the end of the prcoess.
What does this mean for us? Avastin is still approved and available for the treatment of some other kinds of cancer, and that means that it is still "out there" and can be used to treat breast cancer. However, and this is a big "however", it is likely that Medicare and other insurance companies will no longer pay for its use for advanced breast cancer. Since a year's worth of treatment costs close to $100,000, this is a big deal. In Massachusetts, this is not an issue as our state (Hurray for us) prohibits insurance companies refusing to pay for drugs used "off line"( which is what this would be called). In most of the country, however, this is not the case.
This was a painful and difficult and highly pressured decision for the FDA. The evidence was the avastin does not prolong life for women with metastatic breast cancer, and may even hasten death with a couple of potentially life-ending side effects. There do indeed seem to be women for whom it is helpful, and the ongoing research will try to find ways to identify who they are.
This is from the New York Times. Per usual, I give you the beginning and then a link:
F.D.A. Revokes Approval of Avastin for Use as Breast Cancer Drug
Published: November 18, 2011The commissioner of the Food and Drug Administration on Friday revoked the approval of the drug Avastin as a treatment for breast cancer, ruling on an emotional issue that pitted the hopes of some desperate patients against the statistics of clinical trials.
The commissioner, Dr. Margaret A. Hamburg, said that clinical trials had shown that the drug was not helping breast cancer patients to live longer or to meaningfully control theirtumors, but did expose them to potentially serious side effects like severe high blood pressure and hemorrhaging.
"Sometimes, despite the hopes of investigators, patients, industry and even the F.D.A. itself, the results of rigorous testing can be disappointing," Dr. Hamburg told reporters Friday. "This is the case with Avastin when used for the treatment of metastatic breast cancer."http://tinyurl.com/83yohte