Eurpean Ad Comm recommends Gazyvaro

|By:, SA News Editor

The EU Committee for Medicinal Products for Human Use recommends that the EC approve Roche's (RHHBY) Gazyvaro (obinutuzumab) in combination with chlorambucil for the treatment of adults with chronic lymphocytic leukemia (CLL) who have comorbidities making them unsuitable for full-dose fludarabine.

In a Phase 3 trial Gazyvaro plus chlorambucil reduced the risk of disease worsening or death by 86% and increased survival time in untreated CLL patients who received chlorambucil alone.

The EC's full decision should occur in the next several months. The product is already approved in the U.S. and rest of the world.