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 on the sBLA
- read this article 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
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