Genentech announced that the Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for Gazyva (obinutuzumab) in combination with chlorambucil chemotherapy in patients with previously untreated chronic lymphocytic leukemia (CLL)

The sBLA includes complete response (CR) and minimal residual disease (MRD) data from Stage 2 of the Phase 3 CLL11 study that compared Gazyva plus chlorambucil vs. Rituxan (rituximab) plus chlorambucil in a head-to-head study; overall survival (OS) data from Stage 1 of the study comparing Gazyva plus chlorambucil vs. chlorambucil alone was also included. Treatment with Gazyva plus chlorambucil showed significant improvements across multiple study endpoints vs. Rituxan plus chlorambucil. 

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Key study data points added to the label include: 

  • Gazyva plus chlorambucil resulted in a longer progression-free survival (PFS) than Rituxan plus chlorambucil (median PFS: 26.7 months vs. 14.9 months, respectively, HR 0.42, 95% CI 0.33–0.54, P<0.0001).
  • Gazyva plus chlorambucil nearly tripled the number of people showing no evidence of disease (CR) compared to Rituxan plus chlorambucil (26.1% vs. 8.8%, respectively).
  • Of the people who achieved a complete response with or without complete recovery from abnormal blood cell counts, 19% (18/94) of people in the Gazyva arm vs. 6% (2/34) of people in the Rituxan arm were MRD negative in the bone marrow, and 41% (39/94) of people in the Gazyva arm vs. 12% (4/34) people in the Rituxan arm were MRD negative in the peripheral blood.
  • Data from the Stage 1 of the CLL11 study showed that at nearly 2 years, the rate of death was 9% (22/238) for people who received Gazyva plus chlorambucil vs. 20% (24/118) for those who received chlorambucil alone (HR 0.41, 95% CI 0.23–0.74). 

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