FDA: Avastin not Effective for Breast Cancer

June 29, 2011

A panel of federal cancer experts from the FDA has deemed the best-selling cancer drug in the world, Avastin, as ineffective in treating breast cancer.

A panel of federal cancer experts from the Food and Drug Administration (FDA) has deemed the best-selling cancer drug in the world, Avastin, as ineffective in treating breast cancer.

This decision occurred after an unprecedented two-day meeting; the FDA had previously ruled against Avastin, made by Roche, stating its reasoning as the does not extend or improves life for breast cancer patients. Roche challenged the ruling of the government regulators, and the FDA agreed to hold a second hearing. The verdict, however, was unchanged.

The FDA panel voted 6-0 against Avastin's effectiveness.

This vote is not binding and can still be overturned, however, as the FDA’s commissioner, Margaret Hamburg, must make the final decision.

Avastin is still approved for a multiplicity of cancers—including types of colon, lung, kidney and brain cancer—and can be used for breast cancer even if the FDA removes approval. Most insurers, however, will not be willing to pay for the $100,000 drug unless it is backed by FDA.

Avastin was FDA approved in 2008, when the agency granted the drug accelerated approval based on indication that it slowed the growth of breast cancer tumors for more than five months when combined with chemotherapy.

Further research, however, showed that the delay was less than three months in follow-up studies, and patients did not live longer. Many also suffered side effects such as hypertension and blood clots.

Still, some cancer experts said they believed that the drug should remain available for patients who are already responding well. According to these experts, Avastin benefits a subset of patients, though it's not yet clear how to identify them.

"There seems to be this perception that there are all these kinder, gentler treatments for metastatic breast cancer, but I'm not aware of those treatments,” said Dr. Kimberly Blackwell, director of the breast cancer program at the Duke Cancer Institute.

"If the label is withdrawn, we will not see a new drug for metastatic breast cancer for another decade," continued Blackwell.