FDA Panel Rejects Avastin for Breast Cancer

WEDNESDAY, June 29 (HealthDay News) -- The blockbuster cancer drug Avastin got soundly rejected late Wednesday as a treatment for metastatic breast cancer by a U.S. health advisory panel that found the medication was not effective and causes dangerous side effects.

By unanimous vote, the panelists rejected the drug maker's appeal of a U.S. Food and Drug Administration recommendation last December to revoke Avastin's approval for breast cancer. The FDA recommendation cited the medication's poor performance in follow-up studies and its potential for serious side effects.

The drug maker, Genentech, now owned by pharmaceutical giant Roche, was given an unusual two-day hearing this week before the six-member advisory group.

Tuesday's opening-day hearing was dominated by patients and physicians who argued, often emotionally, against the drug's revocation.

"For the patients and their supporters, it was the reality that many of them were alive and well with few symptoms, which they and their physicians attributed to the fact that Avastin had a significant treatment benefit for their breast cancer," blogged Dr. Len Lichtenfeld, Deputy Chief Medical Officer for the American Cancer Society, who attended the hearing.

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