Bayer Schering’s Lymphoma Drug Obtains CHMP Positive Opinion

Bayer Schering Pharma has received a positive opinion from the European Committee for Medicinal Products for Human Use recommending Zevalin as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma 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 2008 upon a favorable review by the European Commission. The European Committee for Medicinal Products for Human Use’s (CHMP) 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).

Gunnar Riemann, member of the board of management of Bayer Schering Pharma, said: “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. This therapy option will provide clinicians with a treatment regimen that truly could help many of their patients to an extended progression-free survival.”