ARTICLE | Regulation

Avastin Side-step

New Genentech data for FDA means 3 more months of Avastin sales in breast cancer

September 20, 2010 7:00 AM UTC

By submitting new information to FDA for Avastin bevacizumab for HER2-negative first-line metastatic breast cancer, Genentech Inc. bought itself and patients three months of reimbursed sales, during which time it may be able to follow Tarceva's path in turning around a doubtful outcome at FDA.

The agency, which looked likely to rescind its accelerated approval for the indication when the PDUFA deadline was reached last Friday, now will take three months to review the new data. The accelerated approval will remain intact for that time...