The U.S. Food and Drug Administration or FDA has accepted Genentech's Biologics License Application or BLA for obinutuzumab or GA101 and granted Priority Review in the treatment of chronic lymphocytic leukemia or CLL, one of the most common forms of blood cancer, based on final Stage 1 data from the pivotal CLL11 study. This acceptance follows the GA101 FDA Breakthrough Therapy Designation, received in May 2013. The FDA confirmed that the action date is December 20, 2013.
The FDA is assessing data from the pivotal Phase III CLL11 study, which found that GA101 showed a statistically significant 86 percent reduction in the risk of disease worsening or death when combined with chlorambucil chemotherapy compared to chlorambucil alone in previously untreated people with CLL and co-existing medical conditions. In CLL11, no new safety signals were detected for GA101.
GA101, an investigational medicine designed to attack cells that have a certain marker on their surface, is currently being investigated in a large clinical program, including multiple head-to-head Phase III trials versus rituximab in indolent non-Hodgkin's lymphoma and diffuse large B-cell lymphoma. CLL is one of the most common forms of blood cancer and in 2013, it is anticipated that there would be about 5,000 deaths from CLL in the U.S.
Genentech, a member of the Roche Group (RHHBY.PK), has headquarters in South San Francisco, California.
by RTT Staff Writer
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