EU Approval for Zevalin as First-Line Consolidation Treatment for Follicular Lymphoma

April 28, 2008 - The European Commission has extended the marketing authorization for Zevalin® ([90Y]-ibritumomab tiuxetan) 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. The aim of such a consolidation therapy is the improvement of the effect of an initial induction therapy. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. Zevalin was initially approved in Europe in 2004. It combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and the tumor-destroying power of localized yttrium-90 radiation. Follicular lymphoma is one of the most common types of Non-Hodgkin’s Lymphoma, a tumor of the lymphatic system.

"This news means that many patients with follicular lymphoma will now have access to Zevalin's proven clinical benefits," said Dr. Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. "The approval in first-line consolidation treatment will also help us to further exploit the potential of 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 (FIT). 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). The data were presented for the first time at the 49th Annual Meeting of the American Society of Hematology (ASH) in December 2007.

"It is particularly impressive that with one single infusion of Zevalin, we have achieved prolongation of median progression-free survival by two years, with a favorable toxicity profile," said Professor Anton Hagenbeek, Academic Medical Centre, Amsterdam, the Netherlands, lead investigator of the FIT trial. "The results also show that radioimmunotherapy is a very effective single agent in the treatment of follicular lymphoma."

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