FDA extends label data for Gazyva for Chronic Lymphocytic Leukemia- Genentech/Roche
Genentech, announced that the FDA approved a supplemental biologics license application (sBLA) for Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy in people with previously untreated Chronic Lymphocytic Leukemia (CLL). The sBLA adds to the label data from Stage 2 of the 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 (CR) and minimal residual disease (MRD) data from Stage 2 of the study. Additionally, overall survival (OS) data was added from Stage 1 of the study comparing Gazyva plus chlorambucil to chlorambucil alone.
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