FDA Approves Combo for Indolent Non-Hodgkin Lymphomas

Nick Mulcahy

May 28, 2019

The US Food and Drug Administration (FDA) has approved lenalidomide (Revlimid, Celgene) in combination with rituximab for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL), both of which are also known as indolent non-Hodgkin lymphomas.

The agency said the combo, which has been called Len-R, was approved on the basis of two clinical trials, AUGMENT and MAGNIFY.

In AUGMENT, 358 patients with relapsed or refractory FL or MZL were randomly assigned (1:1) to receive lenalidomide and rituximab (up to 12 cycles) or rituximab and placebo (5 cycles).

For the study's primary endpoint of progression-free survival (PFS), the median PFS was 39.4 months in the lenalidomide group and 14.1 months in the placebo group (hazard ratio, 0.46; 95% confidence interval, 0.34 - 0.62; P < .0001).

The objective response rate (ORR) for patients with FL was 80% in the lenalidomide group compared with 55.4% in the placebo group. For patients with MZL, the ORR was 65% compared with 44%, respectively.

In the single-group component of MAGNIFY, 232 patients with relapsed or refractory FL, MZL, or mantle-cell lymphoma received 12 induction cycles of lenalidomide and rituximab.

In MAGNIFY, for patients with FL, the ORR was 59%. Median response duration was not reached, with a median follow-up of 7.9 months. For patients with MZL, the ORR was 51%. Median response duration was also not reached, with a median follow-up of 11.5 months.

Across the two trials, adverse reactions occurring in at least 20% of patients were neutropenia, fatigue, diarrhea, constipation, nausea, and cough.

The FDA pointed out that the prescribing information includes a boxed warning about the risk for 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 1-21 of repeated 28-day cycles for up to 12 cycles.

The FDA granted this application through priority review and after designating it as an orphan drug.

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