This article is more than 5 years old. Information may no longer be current.
FDA approves Revlimid-based regimen for previously treated follicular, marginal zone lymphoma
Click Here to Manage Email Alerts
The FDA approved the combination of lenalidomide and a rituximab product for patients with previously treated follicular lymphoma and marginal zone lymphoma, according to press releases from the administration and the manufacturer.
“Nearly 15 years following the initial FDA approval, Revlimid continues to demonstrate benefits for new patient populations,” Jay Backstrom, MD, MPH, chief medical officer for Celgene, said in a press release. “Revlimid in combination with rituximab 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.”
The approval of this regimen was based on two clinical trials that found higher PFS and response rates among patients who took lenalidomide (Revlimid, Celgene) in combination with rituximab compared with rituximab and placebo.
In the randomized AUGMENT trial — which involved 358 patients with relapsed or refractory follicular lymphoma (n = 295) or marginal zone lymphoma (n = 63) — researchers observed median PFS of 39.4 months (95% CI, 22.9 to not reached) with lenalidomide and rituximab vs. 14.1 months (95% CI, 11.4-16.7) with rituximab and placebo (HR = 0.46; 95% CI, 0.34-0.62).
The objective response rate among patients with follicular lymphoma was 80% (95% CI, 73-86) in the lenalidomide arm vs. 55.4% (95% CI, 47-64) in the placebo arm. The objective response rate among patients with marginal zone lymphoma was 65% (95% CI, 45-81) in the lenalidomide arm vs. 44% (95% CI, 26-62) in the placebo arm.
The single-arm portion of the MAGNIFY trial included 232 patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma or mantle cell lymphoma who received 12 induction cycles of lenalidomide and rituximab.
Results showed objective response rates of 59% (95% CI, 51-66) for patients with follicular lymphoma (median follow-up, 7.9 months; 95% CI, 4.6-9.2) and 51% (95% CI, 36-66) for patients with marginal zone lymphoma (median follow-up, 11.5 months; 95% CI, 8-18.9).
Median duration of response was not reached for either group.
The recommended dose of lenalidomide for patients with either form of lymphoma is 20 mg once daily on days 1 to 21 of as many as a dozen 28-day cycles.
The most frequent adverse events among at least 20% of patients included neutropenia, fatigue, diarrhea, constipation, nausea and cough.
“Chemotherapy continues to be a standard of care for indolent forms of NHL, but most patients will relapse or become refractory to their current treatment,” Meghan Gutierrez, CEO of the Lymphoma Research Foundation, said in a press release. “This approval represents a new therapeutic option for previously treated patients with follicular and marginal zone lymphomas, including those who relapse or no longer respond to initial treatment. We commend the patients and scientists who participated in the clinical study for advancing lymphoma research and treatment.”