FDA approves lenalidomide for follicular and marginal zone lymphoma
On May 28, 2019, the Food and Drug Administration approved lenalidomide (REVLIMID®, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).
The MAGNIFY clinical trial evaluated 232 patients with relapsed or refractory FL, MZL, or mantle cell lymphoma treated with lenalidomide and rituximab. Overall 59% of FL and 51% o f MZL patients responded to treatment
In the AUGMENT trail 358 patients with relapsed or refractory FL or MZL were treated with either lenalidomide and rituximab or rituximab and placebo. The overall response for patients with follicular lymphoma was 80% and 65% for marginal zone lymphoma. The average time to cancer progression was 39.4 months for lenalidomide treated patients compared to only 14.1 months rituximab alone.
Side effects occurred across both trials with the most common being neutropenia, fatigue, diarrhea, constipation, nausea, and cough which occurred in at least 20% of patients were
The FDA required a Boxed Warning alerting health care professionals and patients about the risk of embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism which may be life-threatening or fatal.
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