On May 23, 2014 Roche reported that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve Gazyvaro in combination with chlorambucil for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) who have comorbidities making them unsuitable for a certain type of chemotherapy (full-dose fludarabine) (Press release Hoffmann-La Roche, MAY 23, 2014, View Source [SID:1234500534]). Gazyvaro is marketed as Gazyva in the U.S. and the rest of the world.
The CHMP opinion is based primarily on data from the phase III CLL11 study that was conducted in close collaboration with the German CLL Study Group. The study showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly lengthening the amount of time people lived without their disease worsening (progression free survival; PFS) compared to chlorambucil alone and compared to MabThera (rituximab) plus chlorambucil while also increasing the depth of remissions as measured by Minimal Residual Disease (MRD). Gazyvaro plus chlorambucil also increased survival time for previously untreated CLL patients compared to those who received treatment with chlorambucil alone. Data from the study was recently published in the New England Journal of Medicine.
Roche expects a final decision from the European Commission in the coming months.