FDA Grants Priority Review to Leukemia Drug Obinutuzumab

The Global Innovations - Conscious Design To Thrive Global Health

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for obinutuzumab (GA101) and granted Priority Review for GA101 in the treatment of chronic lymphocytic leukemia (CLL), one of the most common forms of blood cancer, based on final Stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013.

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