FDA Urged to Withdraw Approval of Avastin for Breast Cancer Treatment

by VR Sreeraman on  July 21, 2010 at 6:16 PM Drug News
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A panel of experts on Tuesday recommended that the US Food and Drug Administration (FDA) withdraw approval of Roche's best-selling cancer drug Avastin for the treatment of breast cancer.
 FDA Urged to Withdraw Approval of Avastin for Breast Cancer Treatment
FDA Urged to Withdraw Approval of Avastin for Breast Cancer Treatment

Experts on the advisory panel voted 12 to one to recommend that the FDA remove the indication from Avastin's label that the drug be used with chemotherapy to treat advanced breast cancer.

The recommendation came after trials showed that taking Avastin did not benefit patients with metastatic breast cancer and "that there were, indeed, more side effects when patients took Avastin," FDA spokeswoman Karen Riley told AFP.

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 final decision on whether to remove the breast cancer indication from the Avastin label will be taken by the FDA and will only affect the use of Avastin to treat breast cancer patients in the United States.

"The recommendation does not impact the use of Avastin for advanced breast cancer in other countries," Genentech, the Roche-owned pharmaceutical company that makes Avastin, said in a statement.

Riley was unable to say when the FDA will make its decision on whether or not to remove the breast cancer indication from Avastin's US label. Genentech said the decision was expected by mid-September.

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

Source: AFP

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