The Food and Drug Administration (FDA) has approved Revlimid (lenalidomide; Celgene) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL).

The approval was based on the randomized, double-blind, phase 3 AUGMENT study that evaluated the efficacy and safety of Revlimid in combination with rituximab vs rituximab plus placebo in patients with previously treated FL (N=295) and MZL (N=63). The study included patients diagnosed with Grade 1, 2 or 3a follicular lymphoma, who received at least 1 prior systemic therapy, were refractory or relapsed, but not rituximab-refractory. The primary endpoint was progression-free survival (PFS), defined as the time from date of randomization to the first observation of disease progression or death due to any cause.

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Results showed that Revlimid in combination with rituximab was associated with a statistically significant improvement in median PFS of 39.4 months compared with a median PFS with rituximab plus placebo of 14.1 months (hazard ratio [HR]: 0.46; 95% CI, 0.34-0.62; P <.0001). In addition, overall survival (secondary endpoint) improved in patients treated with Revlimid plus rituximab compared with rituximab plus placebo (16 vs 26 deaths) (HR: 0.61; 95% CI, 0.33-1.13). The most common adverse reactions reported were neutropenia, diarrhea, constipation, cough, fatigue, rash, pyrexia, leukopenia, pruritus, upper respiratory tract infections, abdominal pain, anemia, headache, and thrombocytopenia.

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“Revlimid in combination with rituximab (R2) leads to immune-mediated treatment effects and represents a chemotherapy-free treatment option that can help patients with previously treated follicular lymphoma and marginal zone lymphoma delay disease progression,” said Jay Backstrom, MD, MPH, Chief Medical Officer for Celgene.

Revlimid, a thalidomide analogue, is also indicated for the treatment of multiple myeloma, mantle cell lymphoma, and for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. The product is only available via a REMS program.

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This article originally appeared on MPR