Avastin re-submitted to FDA

Perhaps the second time is the charm for Genentech. The biotech has re-submitted a sBLA to the FDA for Avastin in combination with paclitaxel chemotherapy as a first-line treatment for metastatic breast cancer. In September 2006 Genentech was dealt a setback when the FDA asked to see more data, including an independent review, before it would approve the new indication. Genentech supplied the additional information and the six-month FDA review process will now begin.

- here's the release [1] on the sBLA
- read this article [2] from Forbes

ALSO: Watch a blockbuster cancer drug become a behemoth: Roche has won European regulatory approval for treatment of advanced non-small cell lung cancer with Avastin. FiercePharma [3]

Related Articles:
Genentech touts pipeline prospects as doubts fester. Report [4]
Genentech fights to keep edge in drug development. Report [5]
FDA deals setback to Genentech. Report [6]