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Avastin Rejection Supported by Cancer Experts
Date:7/4/2011

By Steven Reinberg
HealthDay Reporter

FRIDAY, July 1 (HealthDay News) -- Oncologists and even some breast cancer support groups are endorsing a U.S. health advisory panel's recommendation that the blockbuster cancer drug Avastin be removed for use in metastatic breast cancer.

The reason: There's still a lack of understanding of how the drug works or who it helps.

Avastin was given fast-track approval by the U.S. Food and Drug Administration in 2008 to be used, in combination with the chemotherapy drug Taxol, by women with metastatic HER2-negative breast cancer.

But a six-member FDA panel of cancer experts said Wednesday that the drug was not effective, caused dangerous side effects and its approval should be revoked.

The decision, which is non-binding, came at the end of a two-day hearing granted to Avastin maker Genentech after the FDA recommended last December revoking the drug's approval for metastatic breast cancer. The FDA cited the medication's poor performance in follow-up studies and its potential for serious side effects.

Karuna Jaggar, executive director of Breast Cancer Action, told HealthDay that "the panel made the right decision. We have been advocating for the FDA to take a critical stand on Avastin and really focus on overall survival," which hasn't been proven by any of the drug's studies so far.

Dr. Paula Klein, an oncologist specializing in breast cancer at Beth Israel Medical Center in New York City, said there may well be a subset of women for whom Avastin will extend life. But she faulted the drug maker for not trying to identify that group. "What Genentech has failed to do is spend the money necessary to find the subset of breast cancer patients that will benefit," she said.

Jaggar said she wished the evidence supporting Avastin had been stronger. She said she would support having Genentech doing a trial to try to identify women who would benefit from the
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