By Mark Ratner

The US Food and Drug Administration sent shockwaves through the medical community last year when it stated its plans to revoke marketing approval for the monoclonal antibody treatment Avastin (bevacizumab) in combination with the chemotherapy drug paclitaxel for first-line treatment of metastatic breast cancer. But rather than taking the blow sitting down, Genentech—which makes Avastin—is contesting the FDA’s plans. The drugmaker’s move, in the form of a 98-page petition submitted in January in support of its request for a public hearing, is unprecedented, and some analysts quietly worry it could jeopardize the goodwill between the company and regulators.

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