CHMP recommends expanded label for Zevalin

German drugmaker 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. The product would receive marketing authorization for all European Union member states as a treatment for this indication later this year upon a favorable review by the European Commission.

The agent is currently approved for adult patients with rituximab-relapsed or refractory CD20-positive follicular B-cell non-Hodgkin's lymphoma in Europe. 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 NHL, a tumor of the lymphatic system.

The CHMP's decision is based on data from the pivotal Phase III FIT trial which showed that Zevalin, when used as first-line consolidation therapy, significantly prolonged progression-free survival time from 13.5 months in the control arm to 37 months in treated patients (p<0.0001).