Pharmaceutical Business review

EU extends marketing authorization for Bayer’s Zevalin

The decision by the European Commission to grant extended marketing authorization to Zevalin is based on data from the pivotal Phase III First-Line Indolent Trial. It showed that Zevalin, when used as first-line consolidation therapy, significantly prolonged the median progression-free survival time from 13.5 months (control arm) to 37 months (p<0.0001). Gunnar Riemann, member of the board of management of Bayer Schering Pharma, said: "This news means that many patients with follicular lymphoma will now have access to Zevalin's proven clinical benefits. The approval in first-line consolidation treatment will also help us to further exploit the potential of Zevalin."