Genentech, Inc. has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for their agent Avastin® (bevacizumab) to be used as second-line therapy in glioblastoma.
The application is based on the BRAIN trial, a Phase II trial evaluating Avastin as a single agent or in combination with Camptosar® (irinotecan) among patients with previously treated glioblastoma.
If the sBLA is accepted by the FDA, an accelerated approval would be considered that allows provisional approval for life-threatening diseases based on preliminary evidence suggesting a clinical benefit.
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