FDA approves Revlimid + Rituxan for follicular lymphoma or marginal zone lymphoma.

The FDA has approved Revlimid (lenalidomide), from Celgene, in combination with a Rituxan (rituximab product) (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. This is the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin’s lymphoma (NHL) that does not include chemotherapy.

The approval of R2 is based primarily on results from the randomized, 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) and MZL (n=63). In the AUGMENT study, treatment with R2 demonstrated a statistically significant improvement in the primary endpoint of progression-free survival (PFS), evaluated by an independent review committee, versus rituximab-placebo. The median PFS was 39.4 months for patients treated with R2 and 14.1 months for those treated with rituximab-placebo (HR: 0.46; 95% CI, 0.34-0.62; P<0.0001). Median follow-up time was 28.3 months (range, 0.1-51.3) in the intent to treat population (n=358). Although not statistically powered to detect a difference in overall survival, a numeric trend for improvement in overall survival (a secondary endpoint) was also seen with R2 versus rituximab-placebo (16 vs. 26 deaths) (HR: 0.61; 95% CI, 0.33-1.13).

Comment: A Marketing Authorization Application for R2 is currently under review by the European Medicines Agency for the treatment of relapsed/refractory FL and MZL. A supplemental new drug application was also submitted to the Japanese Pharmaceuticals and Medical Devices Agency for an additional indication as well as dosage and administration updates for lenalidomide in combination with rituximab for the treatment of relapsed/refractory indolent B-cell NHL.