Medication Monitor

Generic Name (Trade Name—Company)
June 13, 2019


(Revlimid—Celgene Corp.)
FDA approves lenalidomide for follicular and marginal zone lymphoma

On May 28, 2019, FDA approved lenalidomide in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

Approval was based on two clinical trials: AUGMENT (NCT01938001) and MAGNIFY (NCT01996865). In AUGMENT, 358 patients with relapsed or refractory FL or MZL were randomized (1:1) to receive lenalidomide and rituximab or rituximab and placebo. In the single-arm component of MAGNIFY, 232 patients with relapsed or refractory FL, MZL, or mantle cell lymphoma received 12 induction cycles of lenalidomide and rituximab.

The most common adverse reactions were neutropenia, fatigue, diarrhea, constipation, nausea, and cough.

The prescribing information includes a boxed warning alerting health professionals and patients about the risk of embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism, which may be life-threatening or fatal.

The recommended lenalidomide dose for FL or MZL is 20 mg once daily orally on days 1 to 21 of repeated 28-day cycles for up to 12 cycles.