Avastin Not Safe or Effective for Breast Cancer: FDA Confirms

by Thilaka Ravi on  June 30, 2011 at 8:36 AM Drug News   - G J E 4
An advisory panel to the US Food and Drug Administration confirmed its earlier recommendation that the drug Avastin be stripped of its label for use in breast cancer after a rare appeal by the drugmaker.
 Avastin Not Safe or Effective for Breast Cancer: FDA Confirms
Avastin Not Safe or Effective for Breast Cancer: FDA Confirms

The panel voted 6-0 that the evidence shows it is not safe or effective against breast cancer, after the Swiss pharmaceutical giant Roche on Tuesday launched a two-day appeal asking the FDA to reconsider.

The FDA panel had already decided in December that Avastin did not prolong life in breast cancer patients and caused severe side effects, and urged the FDA to take steps to revoke market approval and change the drug's label.

The drug, also known as bevacizumab, carries risks such as severe high blood pressure and hemorrhage and does not prolong overall survival in women suffering from breast cancer, the panel said.

Avastin had been approved for treatment of advanced breast cancer under the FDA's accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases.

The panel's recommendation did not affect the use of Avastin to treat other cancers, including colon and lung cancers.

A final decision by the FDA commissioner must be issued, though a date for that has not been announced. The FDA does not have to follow the recommendations of the expert panel but it usually does.

Genentech, the Roche-owned US pharmaceutical company that makes Avastin, said the drug would remain FDA-approved for use in combination with the chemotherapy drug paclitaxel for first-line treatment of metastatic HER2-negative breast cancer until the FDA makes a final decision.

European medical experts have urged that the drug be restricted to use in combination with paclitaxel only instead of other forms of chemotherapy because benefits were uncertain.

Source: AFP

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