FDA Panel Rejects Avastin for Breast Cancer

An FDA advisory panel voted by a 5-4 margin to recommend against approval of Genentech's (DNA) blockbuster oncology drug Avastin for treatment of advanced breast cancer. The $1.85 billion drug is already approved in the U.S. for colon and lung cancer and in Europe for breast cancer. Though the FDA usually follows the recommendations of its panels, the closeness of the vote leaves open the possibility that it might approve the drug. Four of the nay votes came from statisticians and consumer advocates; four of the yea votes came from oncologists. Genentech's hopes were based on a study by the National Cancer Institute that showed that patients taking Avastin in combination with a chemotherapy drug had a longer period of "progression-free survival" than those taking the chemotherapy drug alone (11.3 months with; 5.8 months without). Some panel members claimed that because the patients on Avastin did not live substantially longer, there is not enough of a survival benefit to justify approval, particularly in view of safety issues. "These patients are terminal, and it's our job to make their lives better, not to say that it's OK to have a stroke or that it's manageable," said Maha Hussain, the advisory panel's chairwoman. "[Genentech] didn't show that patients are living better or that they're living longer." Genentech shares closed down 8.4% at $66.64.

Sources: Wall Street Journal, MarketWatch, Bloomberg, TheStreet.com, Dow Jones
Additional Reading: Genentech Stock Slide: FDA Meeting Should Have Been Webcast

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