European Commission approves Revlimid + Rituxan for follicular lymphoma.- Celgene/BMS

Celgene/Bristol-Myers Squibb announced that the European Commission (EC) has approved a new indication for Revlimid (lenalidomide), in combination with Rituxan (rituximab anti-CD20 antibody), for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). This combination of Revlimid and rituximab (R2) is the first chemotherapy-free combination regimen approved for patients with FL by the EC.

The approval of R2 is based primarily on results from the randomized, multi-center, double-blind, phase III AUGMENT study, which evaluated the efficacy and safety of the R2 combination versus rituximab plus placebo in patients with previously treated FL (n=295) or marginal zone lymphoma (MZL) (n=63). In AUGMENT, treatment with R2 demonstrated a statistically significant improvement in the primary endpoint of median progression-free survival (PFS) (EMA Censoring Rules), evaluated by an independent review committee, versus rituximab plus placebo. The median PFS was 39.4 months for FL patients treated with R2 and 13.8 months for those treated with rituximab-placebo (HR: 0.40; 95% CI, 0.29-0.55; P<0.0001). median follow-up time was 29.2 months range 0.5-50.9 in the intent to treat population n="295).">

In AUGMENT the adverse reactions of any grade observed more frequently in the FL R2 arm compared with the placebo/rituximab arm (with at least 2% higher frequency between arms) were neutropenia (58.2%), diarrhea (30.8%), leukopenia (28.8%), constipation (21.9%), cough (21.9%) and fatigue (21.9%).

In addition to AUGMENT, findings from the MAGNIFY study were included as support for the safety and the efficacy of Revlimid plus rituximab in patients with relapsed or refractory FL, including rituximab refractory FL patients.