In a surprise turn of events, biotech blogs have been reporting that two members of the FDA’s expert panel, who’d previously advised against approval, now say they want to change their vote—which would tip the balance in Genentech’s favor.
Bottom line, exactly how effective is Avastin for women with metastatic breast cancer? The initial study results, the data that guided the FDA’s expert panel, showed a slowing of breast cancer’s progression; but there’s not yet enough data to know whether Avastin also lengthens survival time. In addition, Avastin’s potential side effects are quite serious: six (of 363) women in the trial died due to Avastin-precipitated heart damage. If, as reported, the AVADO trial shows similar results to the initial trial, then those side effects haven’t gone away; and the survival time issue still hasn’t been resolved. While the AVADO trial does indeed reinforce the results of the initial trial, is that enough to steer the FDA away from its expert panel’s recommendation to reject the drug?
Genentech and Roche investors certainly hope so. As breast cancer survivors, and potential future customers for Avastin, our hope might be that the FDA approves Avastin. And we must trust that the FDA’s approval would be based on the drug’s effectiveness–not on how its decision would go down on Wall Street.
Postscript: The FDA announced late Friday that it has approved Avastin for breast cancer treatment. "The FDA has lowered the bar under pressure from the industry,” said Barbara Brenner, executive director of Breast Cancer Action in San Francisco, quoted in The San Francisco Chronicle. Dr. Lisa Bailey, a breast cancer surgeon and past president of the California division of the American Cancer Society–also interviewed in the Chronicle—said, "I'm glad they're (FDA officials) considering other things besides survival. I think that's very important, because quality-of-life issues need to be included. This potentially gives women more options."
In after-hours trading, Genentech stock rose $5.80 (8 percent) on news of the approval.
