Avastin debate spills over until June FDA hearing

By Dr. Ananya Mandal, MDFeb 27 2011

The U.S. Food and Drug Administration have granted Roche a hearing in June to defend the cancer treatment Avastin. The hearing would examine the effectiveness of the drug in breast cancer.

FDA’s oncologic drugs advisory committee would hear the arguments. It is the same panel that overwhelmingly voted to strip the breast cancer indication last July. It was December that the FDA started the process of withdrawing the breast cancer approval for Avastin. Now the panel is being asked to “provide advice and recommendations,” according to a letter from the FDA about the decision to grant the hearing.

Avastin is prescribed in combination with chemotherapy drugs and is used in breast, colon, kidney, brain, and a common type of lung cancer. It is Roche’s top-selling product. While clinical data has shown adding Avastin to chemotherapy to treat colon and lung cancer increases patients’ survival time, the benefit is not as clear in other cancers raising questions of efficacy. Avastin had about $6.8 billion in global sales last year, growing 9% from a year earlier and making up 14% of Roche’s total.

Hal Barron, Roche’s chief medical officer and head of global product development, said the company believed Avastin “is an important option for women with this disease and should remain an FDA-approved choice.” He added, “We appreciate the opportunity to continue our discussion with the FDA during a public hearing about the use of Avastin in metastatic breast cancer.” At least since the hearings are scheduled for June 28 and 29, Avastin would remain approved for usage in the U.S. for breast cancer until then. Most insurers are still paying for its use against breast cancer. An FDA spokeswoman said the final decision would be made by the FDA commissioner sometime after the hearing.

A spokeswoman for the non-profit Breast Cancer Action group said the meeting could be productive if it leads to reforms in how the FDA reviews and approves cancer drugs. “But if this is just going to be about Roche buying their way into the FDA and putting profits before patients, then I think this meeting is going to be highly questionable,” said Angela Wall, communications manager for the San Francisco-based advocacy group.