Roche's Gazyvaro approved in Europe for follicular lymphoma

Swiss pharma giant Roche (ROG: SIX) has received approval from the European Commission for 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.

The approval is based on results from the pivotal Phase III GADOLIN study which showed that Gazyva/Gazyvaro plus bendamustine, followed by Gazyva/Gazyvaro alone resulted in a 52% reduction (HR=0.48, 95% CI 0.34-0.68, p<0.0001) 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 Gazyva/Gazyvaro regimen was more than double that with bendamustine alone (29.2 months versus 13.7 months; HR=0.48, 95% CI 0.35-0.67, p<0.0001). People who received the Gazyva/Gazyvaro regimen also showed a 38% reduction (HR=0.62, 95% CI 0.39-0.98) in the risk of death (OS) compared to those who received bendamustine alone.

Indication could add as much as $1 billion to Gazyvaro’s peak sales