Advisory Committee to Discuss New Avastin Indication

The FDA’s Oncologic Drugs Advisory Committee will meet Dec. 5 to discuss a new indication for Genentech’s cancer drug Avastin.

Genentech submitted a supplemental biologics license application for Avastin (bevacizumab) to treat patients who have not received chemotherapy for locally recurrent or metastatic HER-2 negative breast cancer.

Genentech has come under fire lately for limiting Avastin’s availability with a new policy that bans wholesalers from selling the drug to compounding pharmacies that repackage it for use in patients with wet age-related macular degeneration.

Although Avastin is not approved for ophthalmologic use, physicians use it instead of Genentech’s chemically similar drug Lucentis (ranibizumab), which is considerably more expensive.

Senate Special Committee on Aging Chairman Herb Kohl (D-Wis.) opposed the company’s new policy, saying it would cost taxpayers billions of dollars through higher Medicare costs. Genentech said it would delay implementing its new distribution policy until Jan. 1, 2008.

More information on the meeting can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/2007-4332-nm00001.pdf.