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news.Bayer Schering Pharma has announced that the European Commission has extended the marketing authorization for Zevalin in Europe. Zevalin can now be used in the course of a first-line therapy after remission induction in previously untreated patients with follicular lymphoma.
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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."