Zevalin® Receives Positive CHMP Opinion in Europe for First-Line Consolidation Treatment

Posted Atbayer.com

Berlin, March 20, 2008 – Bayer Schering Pharma AG has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending Zevalin® ([90Y]-ibritumomab tiuxetan) as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma (FL) in Europe. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. The product would receive marketing authorization for all EU member states as a treatment for this indication later this year upon a favorable review by the European Commission. Zevalin is currently approved for adult patients with rituximab relapsed or refractory CD20-positive follicular B-cell Non-Hodgkin’s Lymphoma (NHL) in Europe. It combines the tumor-targeting ability of an anti-CD20 monoclonal antibody and the tumour-destroying power of localised yttrium-90 radiation. Follicular lymphoma is one of the most common types of Non-Hodgkin’s Lymphoma (NHL), a tumor of the lymphatic system.

“The CHMP’s recommendation represents an important milestone for Zevalin, as it recognizes the potential value that consolidation therapy with Zevalin can offer to patients with follicular lymphoma,” said Dr. Gunnar Riemann, member of the Board of Management of Bayer Schering Pharma AG. “This therapy option will provide clinicians with a treatment regimen that truly could help many of their patients to an extended progression-free survival.”

The CHMP’s decision is based on data from the pivotal Phase III First-Line Indolent Trial (FIT) that showed Zevalin, when used as first-line consolidation therapy, significantly prolonged progression-free survival time from 13.5 months (control arm) to 37 months (p<0.0001). The data was presented for the first time at the 49th Annual Meeting of the American Society of Hematology meeting in December 2007.