Genentech submits Avastin NSCLC sBLA
US biotechnology major Genentech has submitted a supplemental Biologics License Application to the Food and Drug Administration for its cancer drug Avastin (bevacizumab) in combination with platinum-based chemotherapy for first-line treatment of advanced, non-squamous, non-small cell lung cancer.
California-headquartered Genentech has requested a priority review for the submission, which means that, if accepted, the FDA would take action on the application by October. The company also plans to submit an sBLA for the agent, which is currently approved as a first-line treatment of metastatic colorectal cancer in combination with intravenous 5-fluorouracil-based chemotherapy, for metastatic breast cancer in the second quarter of the year.
The sBLA submission is based on results from a randomized, controlled, multicenter Phase III trial that enrolled 878 patients which showed that subjects receiving Avastin plus paclitaxel and carboplatin chemotherapies had a 25% improvement in overall survival, the trial's primary endpoint.
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