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.
“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.”
The FDA is evaluating data from the pivotal Phase III CLL11 trial, which found that GA101 demonstrated a statistically significant 86 percent reduction in the risk of disease worsening or death (HR=0.14, 95 percent CI 0.09-0.21, p<0.0001) 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. The most common Grade 3-4 adverse events (AEs) for GA101 were infusion-related reactions (IRRs) and low cell count of certain white blood cells (neutropenia) which did not result in an increased risk of infection. The incidence and severity of IRRs decreased after the first infusion and no Grade 3-4 IRRs have been reported beyond the first infusion.
Marketing applications have also been submitted to other regulatory authorities, including the European Medicines Association (EMA), in April 2013. In the United States, Genentech has opened an Expanded Access Program (EAP) to provide GA101 to people with CLL under certain circumstances while the company seeks regulatory approval.