FDAnews Drug Daily Bulletin

ROCHE, GENENTECH FILE SBLA FOR AVASTIN

April 21, 2006
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Roche and Genentech have submitted a supplemental biologics license application (sBLA) to the FDA to market Avastin for lung cancer. The drug treats non-squamous, non-small cell lung cancer (NSCLC).

The companies have filed for use of Avastin (bevacizumab) in combination with a platinum-based chemotherapy (carboplatin plus paclitaxel) for previously untreated patients suffering from advanced NSCLC.

Avastin is the first treatment to inhibit angiogenesis -- the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues -- the companies said. The drug targets vascular endothelial growth factor (VEGF), a naturally occurring protein that is a key mediator of angiogenesis. Avastin chokes off the blood supply that allows tumors to metastasize, or grow and spread throughout the body.

Lung cancer is the second most common cancer, and the leading cause of cancer-related deaths, according to the National Cancer Institute.