FDA panel to review Avastin for breast cancer

Last Updated: 2007-09-14 12:00:33 -0400 (Reuters Health)

By Lisa Baertlein

LOS ANGELES (Reuters) - Genentech Inc.'s blockbuster drug Avastin will be reviewed as a first-line treatment for metastatic breast cancer by a U.S. Food and Drug Administration advisory panel in December, the company said on Thursday.

Avastin is currently approved to treat colon and lung cancers although doctors already prescribe it as an off-label treatment for breast cancer patients.

Breast cancer is the second leading cause of death in women after lung cancer and analysts say FDA approval for the new use would boost Avastin sales, which were $564 million in the second quarter.

Genentech said the FDA's Oncologic Drugs Advisory Committee will consider its application to use Avastin (bevacizumab) in combination with paclitaxel chemotherapy for patients who have not yet received chemotherapy.

The FDA is due to take action on the application by Feb. 23, 2008, Genentech said in a statement on its Web site.

Genentech, which is majority owned by Swiss drug maker Roche Holding AG, submitted its application for breast cancer use in May 2006.

In September 2006, the FDA asked Genentech to submit additional information including an independent review of scans from patients participating in a late stage trial.

If approved, the Avastin drug combination would compete with FDA-approved treatments such as GlaxoSmithKline's Tykerb with Roche's Xeloda.

Genentech also makes Herceptin, an approved treatment for people with HER2-positive breast cancer, often a more aggressive form that strikes about 25 percent of breast cancer patients.

According to the American Cancer Society, roughly 1 in 8 women will develop invasive breast cancer in their lifetime. The society estimates nearly 40,500 women and 450 men will die from breast cancer in the United States in 2007.