Avastin risks loss of breast-cancer approval

Will Roche hang on to Avastin's breast-cancer indication? That's the question people are asking in advance of Tuesday's FDA advisory panel meeting. The agency released its review of the data--and the verdict wasn't good.

Avastin's benefits to breast cancer patients may not be worth its risks, staff reviewers say. Furthermore, data shows adding the drug to chemotherapy doesn't deliver "clinically meaningful results," the agency concludes.

Since the agency approved Avastin for patients with advanced breast cancer--against the 5-4 vote of an advisory committee--Roche has conducted two additional studies. As required by the accelerated approval process, the drugmaker then submitted that new data to the FDA.

The two follow-up studies "failed to confirm the magnitude" of the benefits seen in that first study of Avastin as a breast cancer treatment. Rather than a five-and-a-half month survival benefit, as in the first study, Avastin delivered less than a month in one of the new studies, and up to 2.9 months in the other, the Wall Street Journal reports.

Yanking Avastin's breast cancer indication could hit the drug's sales hard, analysts say. In fact, it could cut $1 billion from the drug's $6 billion in annual sales by 2015, Sanford C. Bernstein's Jack Scannell tells Bloomberg. "My gut feeling would be that it doesn't look good for Avastin," Mirabaud Securities analyst Nick Turner tells the news service. "The real worry here may be that the adverse events associated with Avastin are overriding any anti-cancer effect."

- see the WSJ piece
- get more from Bloomberg
- read the Reuters news

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