European Commission approves Gazyvaro for treatment of CLL - Roche

Roche today announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated Chronic Lymphocytic Leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Outside of the EU and Switzerland, Gazyvaro is marketed as Gazyva.

The European approval was based on the outcomes of the CLL11 study which was conducted in close collaboration with the German CLL Study Group. The study showed that Gazyvaro plus chlorambucil met its primary endpoint by significantly reducing the risk of disease worsening or death by 61% compared to MabThera/Rituxan plus chlorambucil (progression free survival; PFS). For patients in the Gazyvaro arm, median PFS was 26.7 months compared with 15.2 months for those in the MabThera/Rituxan arm (HR 0.39, CI 0.31-0.49, p<0.001).

Additional Gazyvaro data from the CLL11 study showed higher complete response rates (21% compared with 7%) and a ten-fold increase in the percentage of people achieving minimal residual disease (MRD) negativity (37.7% compared with 3.3%) compared to the MabThera/Rituxan arm of the study. Gazyvaro plus chlorambucil also increased the time people with previously untreated CLL lived (overall survival, OS) compared to those who received treatment with chlorambucil alone.