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PAL coalition memberBreast Cance ...

Posted Oct 30 2008 3:21pm

Avastin

PAL coalition member Breast Cancer Action today issued a statement on the FDA’s denial of Genentech’s [NYSE:DNA] application to have its drug Avastin approved for treatment of metastatic breast cancer. Avastin is currently approved for treatment of metastatic colorectal cancer and advanced non-small cell lung cancer. Genentech has been in the news recently for restricting the availability of Avastin to pharmacies that divide vials of Avastin for use as a treatment for the eye condition macular degeneration. These “off label” uses of Avastin are much less expensive than Genentech’s drug Lucentis, which is approved for macular degeneration. Genentech also came under fire in 2006 for greatly increasing the price of Avastin, in what many saw as a preemptive move in anticipation of what Genentech hope would be FDA approvals for lung cancer and breast cancer. The FDA did approve the drug for advanced non-small cell lung cancer.

Here is Breast Cancer Action’s statement on the Avastin denial:

Breast Cancer Action (BCA) applauds yesterday’s recommendation by a Food & Drug Administration (FDA) advisory committee to deny approval of Avastin as a breast cancer drug for metastatic patients.

In a letter to the Oncologic Drugs Advisory Committee (ODAC), BCA urged denial based on the fact that the drug’s maker, biotech giant Genentech, did not provide data indicating that Avastin improved overall survival or quality of life.

By a 5-4 vote, the committee agreed, indicating that the toxic side effects outweighed the potential benefits of the drug. ODAC member and patient advocate Natalie Compagni Portis told the New York Times that she voted no because while it’s painfully true that metastatic breast cancer isn’t curable, “I don’t think that means that we should just say, ‘Well, here, try this,’ if there isn’t meaningful data to support it.”

BCA Executive Director Barbara A. Brenner told the San Francisco Chronicle, “It’s not necessarily a bad drug. We just don’t know if it’s a good drug.” Brenner also criticized the estimated $100,000 a year price tag for Avastin.

BCA believes that a drug should increase overall survival or improve quality of life before being approved. Additionally, it should be more affordable than the available alternatives.

The recommendation now goes to the FDA commissioner, who will make a decision in February. We will continue taking action–and asking you to do so–on the issue, so stay tuned.

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