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FDA committee to examine new indication for Avastin

11/12/2007

WASHINGTON The FDA’s Oncologic Drugs Advisory Committee is set to review Genentech’s cancer drug, according to reports.

The advisory committee, which will meet Dec. 5, is said to discuss a new indication for Genentech’s cancer drug Avastin.

The company recently submitted an additional biologics license application for Avastin (bevacizumab) to treat patients who have not received chemotherapy for certain types of breast cancer.

Genentech has experienced some backlash from wholesalers and pharmacies over the drug, which is chemically similar to the company’s drug Lucentis, used to treat macular degeneration, a severe eye condition that usually occurs at a later age.

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.

Chairman for the Senate Special Committee on Aging, 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.

In the first six months of this year, Avastin had sales of $1.1 billion and Lucentis had sales of $420 million.

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