Genentech's obinutuzumab gets FDA Priority Review for chronic lymphocytic leukemia

Published on July 3, 2013 at 7:31 AM · No Comments

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: 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.

“These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame.”

"We're excited that the FDA has granted GA101 in CLL both Breakthrough Therapy Designation and Priority Review," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame."

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