EU approves Gazyvaro (obinutuzumab) for follicular lymphoma - Roche

The EMA has approved Gazyvaro (obinutuzumab), from Roche, as a treatment for some patients with previously treated follicular lymphoma. The European Commission has cleared the drug's use alongside bendamustine chemotherapy followed by Gazyvaro alone as a new treatment for patients who have not responded to a MabThera (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.

Approval was based on Phase III results from the GADOLIN study, which showed that in people whose disease progressed during or within six months of prior Rituxan-based therapy, the Gazyvaro-based treatment regimen demonstrated a 52 percent reduction in the risk of disease worsening or death, compared to bendamustine alone. Median progression-free survival was more than double that with bendamustine alone (29.2 months vs. 13.7 months), and those taking Gazyvaro also showed a 38 percent reduction in the risk of death. The most common Grade 3-4 side effects of the Gazyvaro regimen were low white blood cell counts, infusion reactions and low platelet counts.

Comment: Gazyvaro was first authorised in the European Union (EU) in July 2014 for use in combination with chlorambucil in patients with previously untreated chronic lymphocytic leukaemia.