Genentech submits sBLA for Avastin to treat colorectal cancer

By E. Janene Geiss

Philadelphia, Dec. 19 - Genentech, Inc. said Monday that it has submitted a supplemental Biologics License Application with the U.S. Food and Drug Administration 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, according to a company news release.

The submission is based on results of a randomized, controlled, multicenter phase 3 trial (E3200) of 829 patients with advanced or metastatic colorectal cancer whose disease progressed following previous treatment with 5-FU and irinotecan-based chemotherapy, officials said.

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% reduction in the risk of death (hazard ratio of 0.75), the primary endpoint, which is equivalent to a 33% improvement in overall survival, compared to patients who received Folfox4 alone.

"Data from this study showed that adding Avastin to chemotherapy is an important treatment for patients with relapsed metastatic [colorectal cancer]," Hal Barron, senior vice president of development and chief medical officer at Genentech, said in the release.

"We continue to investigate Avastin in clinical trials in more than 20 cancer types, and plan to work closely with the FDA during the review process for this potential new indication in relapsed metastatic [colorectal cancer]," Barron said.

Genentech is a South San Francisco, Calif., biotechnology company that develops biotherapeutics for medical needs.

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