FDA approves sBLA for Genentech's Gazyva

SOUTH SAN FRANCISCO, Calif. — Genentech last week announced that the Food and Drug Administration approved a supplemental biologics license application for Gazyva to be used in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia.

 

According to the company, the sBLA adds to label data from Stage 2 of a CLL11 study that show "significant improvements with Gazyva plus chlorambucil across multiple clinical endpoints when compared head-to-head with Rituxan (rituximab) plus chlorambucil."

 

“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,” said Sandra Horning, M.D., chief medical officer and head of global product development. “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.”

 

Gazyva was approved for use in combination with chlorambucil in people with previously untreated CLL on November 1, 2013, the company stated. The drug is also being investiaged in a development program across various types of blood cancers.