FDA Grants Genentech's Obinutuzumab Priority Review for Previously Untreated CLL

Genentech, a member of the Roche Group OTC: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Biologics License Application (BLA) for … Genentech, a member of the Roche Group OTC: RHHBY), today 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. This acceptance follows the GA101 FDA Breakthrough Therapy Designation that was received in May 2013. “We're excited that the FDA has granted GA101 in CLL both Breakthrough Therapy Designation and Priority Review,” said Hal Barron, M.D., chief