Genentech announced that the FDA has accepted its Biologics License Application (BLA) for obinutuzumab (GA101) and granted Priority Review for obinutuzumab in the treatment of chronic lymphocytic leukemia (CLL).

Obinutuzumab is an investigational medicine designed to attack cells that have a certain marker on their surface. It kills targeted cells both directly and together with the body’s immune system.

The FDA is evaluating data from the pivotal Phase 3 CLL11 trial, which found that obinutuzumab (GA101) demonstrated a statistically significant 86% reduction in the risk of disease worsening or death (HR=0.14, 95% CI 0.09–0.21, P<0.0001) when combined with chlorambucil chemotherapy compared to chlorambucil alone in previously untreated people with chronic lymphocytic leukemia and co-existing medical conditions.

Obinutuzumab (GA101) is currently being investigated in a large clinical program, including multiple head-to-head Phase 3 studies vs. Rituxin (rituximab) in indolent non-Hodgkin’s lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL). In May 2013, the FDA granted obinutuzumab Breakthrough Therapy Designation.

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