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Surprise Approval for Avastin

The FDA approval of the breast cancer treatment, which was opposed by advisory panels, shocked patients, doctors, and investors

When the Food & Drug Administration announced late on Feb. 22 that it had swept aside the objections of its expert advisers and approved Genentech's (DNA) Avastin for breast cancer, investors, patients, and cancer specialists were all caught off guard. The agency rarely goes against the recommendations of its outside advisory panels. The surprising decision set off a new round of speculation about the fate of another cancer drug—Provenge, a controversial prostate cancer treatment from Seattle-based Dendreon (DNDN) that was rejected by the FDA last May, even though an advisory committee determined that the drug was both safe and effective.

Investors hope the Avastin decision heralds a more flexible FDA that will look favorably on Provenge and other cancer drugs in the future. Indeed, Dendreon's stock (BusinessWeek, 6/4/07) inched up on Feb. 25, from 5.29 a share to as high as 5.62, before sinking back to 5.39. But close observers of the agency warn against such conclusions.