EC OKs New Use for Roche’s Cancer Drug
The European Commission has approved Roche’s 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 Roche’s 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 and comorbidities that make them unsuitable for full-dose fludarabine based therapy.
Gazyvaro is marketed as Gazyva outside of the European Union and Switzerland. In February 2016, 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.