16 June 2016 - This is the second approval in Europe for Gazyvaro based on a positive phase III study.

Roche announced today that the European Commission has approved Gazyvaro (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen.

With this approval, Gazyvaro is now approved in Europe to treat two common types of blood cancer. Gazyvaro was previously approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia (CLL) and comorbidities that make them unsuitable for full-dose fludarabine based therapy. That approval was based on data from the pivotal CLL11 study, where the combination of Gazyva/Gazyvaro plus chlorambucil showed superior efficacy when compared head-to-head with MabThera/Rituxan plus chlorambucil and chlorambucil alone.

Gazyvaro is marketed as Gazyva outside of the EU and Switzerland. As announced in February this year, Gazyva received approval by the US Food and Drug Administration in combination with bendamustine followed by Gazyva alone as a treatment for people with follicular lymphoma who did not respond to a Rituxan-containing regimen, or whose follicular lymphoma returned after such treatment, based on the results of the GADOLIN study.

For more details, go to: http://www.roche.com/media/store/releases/med-cor-2016-06-16.htm