CHMP recommend Gazyvaro for CLL - Roche

The EMA's CHMP has recommended that the European Commission approve Gazyvaro (obinutuzumab), from Roche, 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). Gazyvaro is marketed as Gazyva in the US.

The CHMP opinion is based primarily on the Phase III CLL11 study which showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly lengthening 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.