CHMP recommends approval of Revlimid + Rituxan in follicular lymphoma.- Celgene Corp

Celgene Corporation announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Revlimid (lenalidomide) in combination with Rituxan (rituximab anti-CD20 antibody) (R�) for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). If approved by the European Commission (EC), R2 will be the first combination treatment regimen for patients with FL that does not include chemotherapy.

The CHMP positive opinion is based primarily on results from the randomized, multi-center, double-blind, Phase III AUGMENT study, which evaluated the efficacy and safety of the R� combination versus rituximab plus placebo in patients with previously treated FL (n=295). Additionally, findings from the MAGNIFY study were included as support for the safety and the efficacy of lenalidomide plus rituximab in patients with relapsed or refractory FL, including rituximab refractory FL patients.