EC approves Gazyvaro plus bendamustine in follicular lymphoma
Posted: 16 June 2016 | | No comments yet
The EC has approved Gazyvaro in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma…
The European Commission has approved Roche’s Gazyvaro (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma.
The treatment is approved for patients who did not respond or who progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen.
The approval is based on results from the Phase III GADOLIN study which showed that Gazyvaro plus bendamustine, followed by Gazyvaro alone resulted in a 52% reduction in the risk of disease worsening or death (progression-free survival, PFS), compared to bendamustine alone, as evaluated by an independent review committee (IRC). As assessed by investigator review, median PFS with the Gazyvaro regimen was more than double that with bendamustine alone (29.2 months vs. 13.7 months). People who received the Gazyvaro regimen also showed a 38% reduction in the risk of death (OS) compared to those who received bendamustine alone.
Commenting on the approval, Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche, said: “Today’s approval is a significant milestone in the treatment of people with follicular lymphoma in Europe. For those who fail to achieve durable disease control with MabThera-based treatment, Gazyvaro plus bendamustine is an important new treatment option that has been shown to reduce the risk of disease progression or death by more than half.”
Gazyvaro approved to treat two types of blood cancer
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 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. In February, 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.