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.

“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.

For more information visit revlimid.com.

This article originally appeared on MPR