GENENTECH SUBMITS SBLA FOR AVASTIN

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Genentech has submitted a supplemental biologics license application (sBLA) with the FDA for Avastin (bevacizumab) in combination with 5-fluorouracil (5-FU)-based chemotherapy for patients with relapsed, metastatic colorectal cancer. Avastin is currently approved as a first-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.

The sBLA submission is based on results of a randomized, controlled, multicenter Phase III trial of 829 patients with advanced or metastatic colorectal cancer (CRC) whose disease progressed following previous treatment with 5-FU and irinotecan-based chemotherapy. The study showed that patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 25 percent reduction in the risk of death, the primary endpoint, which is equivalent to a 33 percent improvement in overall survival, compared to patients who received FOLFOX4 alone.