Genentech has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for Gazyva (obinutuzumab) in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
The sBLA includes new complete response (CR) and minimal residual disease (MRD) data from Stage 2 of the CLL11 study as well as overall survival data from Stage 1 of the study. Stage 1 of the CLL11 trial studied Gazyva plus chlorambucil compared with chlorambucil alone and Stage 2 compared Gazyva plus chlorambucil to rituximab plus chlorambucil.
The sBLA approval adds to the Gazyva prescribing information that Gazyva plus chlorambucil helped patients have a progression-free survival nearly 1 year longer than those who received rituximab plus chlorambucil (26.7 months vs 14.9 months; HR = 0.42; 95% CI: 0.33 – 0.54; P < 0.0001) and that Gazyva plus chlorambucil tripled the number of complete responses compared with rituximab plus chlorambucil (26.1% vs 8.8%).
In addition, of those who achieved a complete response, more patients who received Gazvya were MRD negative in the bone marrow (19% vs 6%) and the peripheral blood (41% vs 12%) compared with those who received rituximab. Furthermore, 2-year mortality rate was 9% in the Gazyva arm versus 20% in the chlorambucil alone arm (HR = 0.41; 95% CI: 0.23 – 0.74).