FDA approved a supplemental biologics license application for Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia.
The sBLA adds to the label data from Stage 2 of the phase III CLL11 study showing significant improvements with Gazyva plus chlorambucil across multiple clinical endpoints when compared head-to-head with Rituxan (rituximab) plus chlorambucil.
The approval includes complete response and minimal residual disease data from the study. Additionally, overall survival data was added from Stage 1 of the study comparing Gazyva plus chlorambucil to chlorambucil alone. Gazyva is sponsored by Genentech, a member of the Roche Group.
The sBLA approval updated the Gazyva prescribing information with the following data: Gazyva plus chlorambucil helped people with previously untreated CLL live nearly a year longer without their disease worsening or death than Rituxan plus chlorambucil (median PFS: 26.7 months vs. 14.9 months, respectively. HR=0.42, 95 percent CI 0.33-0.54, p<0.0001); and that Gazyva plus chlorambucil nearly tripled the number of people showing no evidence of disease compared to Rituxan plus chlorambucil (26.1 percent vs. 8.8 percent, respectively).
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