FDA Grants Priority Review for Leukemia Drug Obinutuzumab
Approval decision expected in December (July 2)
The FDA has accepted a Biologics License Application (BLA) for obinutuzumab (GA101, Genentech) and has granted the drug priority review for the treatment of chronic lymphocytic leukemia (CLL), one of the most common forms of blood cancer.
The agency’s action date was set for December 20, 2013.
The FDA is evaluating data from the pivotal phase III CLL11 trial, in which obinutuzumab demonstrated a statistically significant 86% reduction in the risk of disease worsening or death (hazard ratio = 0.14; P < 0.0001) when combined with chlorambucil chemotherapy compared with chlorambucil alone in previously untreated patients with CLL and co-existing medical conditions.
The most common grade-3 or -4 adverse events for obinutuzumab were infusion-related reactions (IRRs) and low cell counts 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 of obinutuzumab, and no grade-3 or -4 IRRs have been reported beyond the first infusion.
Obinutuzumab is currently being investigated in a large clinical trial program that includes head-to-head phase III studies versus rituximab in indolent non-Hodgkin’s lymphoma (NHL) and in diffuse large B-cell lymphoma (DLBCL).
Source: Genentech; July 2, 2013.