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FDA grants priority review to Revlimid as part of regimen for follicular, marginal zone lymphomas
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The FDA granted priority review to lenalidomide in combination with rituximab for previously treated follicular lymphoma or marginal zone lymphoma.
Lenalidomide (Revlimid, Celgene) is an immunomodulatory agent approved for treatment of patients with mantle cell lymphoma whose disease relapsed or progressed after treatment with two prior therapies, including bortezomib (Velcade, Takeda/Millennium). The agent also is approved for treatment of certain patients with multiple myeloma or myelodysplastic syndrome.
Celgene submitted a supplemental application seeking approval for the new indication based on results of the randomized phase 3 AUGMENT study.
Researchers assigned patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma to rituximab (Rituxan; Genentech, Biogen) plus lenalidomide or placebo.
Results, presented in December at ASH Annual Meeting, showed patients assigned the lenalidomide-rituximab regimen achieved longer PFS (median, 39.4 months vs. 14.1 months; HR = 0.46; 95% CI, 0.34-0.62). Researchers also reported a higher overall response rate (78% vs. 53%; P < .0001), higher complete response rate (34% vs. 18%; P = .001) and longer median duration of response (36.6 months vs. 21.7 months) in the lenalidomide-rituximab group.
OS data were not mature but, at data cutoff, 16 deaths had been reported in the lenalidomide-rituximab group and 26 had been reported in the control group (HR = 0.61; 95% CI, 0.33-1.13).
All-grade treatment-emergent adverse events that appeared more common in the lenalidomide-rituximab group than the control group included infections (63% vs 49%), cutaneous reactions (32% vs 12%), constipation (26% vs 14%), thrombocytopenia (15% vs 4%), and tumor flare reaction (11% vs 1%).
A higher percentage of patients assigned lenalidomide-rituximab experienced grade 3 or grade 4 treatment-emergent adverse events (69% vs. 32%). These included increased neutropenia (50% vs. 13%) and leukopenia (7% vs. 2%).
Two patients in each group experienced grade 5 treatment-emergent adverse events.
“[Lenalidomide plus rituximab] has the potential to offer patients with previously treated follicular lymphoma and marginal zone lymphoma a chemotherapy free option,” Jay Backstrom, MD, chief medical officer and head of global regulatory affairs for Celgene, said in a company-issued press release. “We look forward to working with the FDA to bring [this] regimen to patients as quickly as possible.”
The FDA is expected to make a decision on the application by June 27.