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

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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

See full press release

Posted-In: News Guidance Contracts FDA Management Global

 

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