Lenalidomide approved by the FDA for follicular and marginal zone lymphoma

The US Food and Drug Administration has approved lenalidomide in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

Two clinical trials contributed to the approval, AUGMENT (NCT 01938001), and MAGNIFY (NCT 01996865). In MAGNIFY, the single-arm component consisted of 232 patients with relapsed or refractory FL, MZL or mantle cell lymphoma. Patients received 12 induction cycles of lenalidomide and rituximab. The objective response rate (ORR) was 59% (104/177; 95% CI, 51%, 66%) for patients with FL, and 51% (23/45; 95% CI, 36%, 66%) for patients with MZL.

Median response duration was not reached, with a median follow-up of 7.9 months in patient with FL, and 11.5 months in patients with MZL.

In AUGMENT, 358 patients with relapsed or refractory (R/R) FL or MZL randomly received either lenalidomide and rituximab, or rituximab and a placebo. The primary endpoint of the study was progression-free survival (PFS), determined by an independent review committee. Median PFS in the lenalidomide arm was 39.4 months and 14.1 months in the placebo arm (HR 0.46; 95% CI, 0.34, 0.62; P<0.0001).

The ORR for patients with FL was 80% (118/147; 95% CI, 73%, 86%) in the lenalidomide cohort, compared with 55.4% (82/148; 95% CI, 47%, 64%) in the control group. The ORR for patients with MZL was 65% (20/31; 95% CI, 45%, 81%), in comparison to the control arm at 44% (14/32; 95% CI, 26%, 62%).

Adverse reactions affecting at least 20% of patients in both studies were neutropenia, fatigue, diarrhea, constipation, nausea and cough.

The recommended dose of lenalidomide for FL or MZL is 20 mg orally once daily on days 1—21 of repeated 28-day cycles (up to 12 cycles). Full prescribing information can be found here, and includes a warning alerting health care professionals about the risk of embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism, which could be life threatening or fatal.