FDA Approves Genentech’s Combination Leukemia Treatment

Genentech has received FDA approval for a supplemental biologics license application (sBLA) 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 CLL11 study, which showed significant improvements with the Gazyva combination compared with a combination of Rituxan (rituximab) plus chlorambucil for the same indication. The approval includes complete response and minimal residual disease data from Stage 2 of the study, and overall survival data from Stage 1 of the study. The FDA originally approved Gazyva, in combination with chlorambucil, for breakthrough therapy designation in November 2013.

"Gazyva is the first and only medicine to significantly help people live without their disease worsening when combined with chlorambucil compared to Rituxan and chlorambucil in people with previously untreated chronic lymphocytic leukemia. These new data enhance our understanding of the disease and its treatment, and this approval affirms an important treatment option for people with this difficult-to-treat disease,” said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, in a press release.

The results of the study noted in the sBLA approval show that patients treated with a combination of Gazyva and chlorambucil lived nearly a year longer without their disease worsening than those who took Rituxan plus chlorambucil; the Gazyva combination nearly tripled the number of patients showing no evidence of the disease; more patients were found to have experienced a full recovery from abnormal blood cell counts compared to those treated with the Rituxan combination; at two years in the study, the death rate of those on the Gazyva combination was 9% compared to a death rate of 20% for those on the Rituxan combination.

Sources:
GenentechFDA