Gazyva obinutuzumab: Phase III data

The open-label, international Phase III GADOLIN trial in 413 patients with indolent NHL refractory to Rituxan rituximab was stopped early after a pre-planned interim analysis by an independent DMC showed that Gazyva plus Treanda bendamustine followed by Gazyva alone met the primary endpoint of improving median PFS vs. Treanda alone. Roche said data from the trial will be submitted to the FDA, EMA and other health authorities for approval. ...