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Tafasitamab receives positive CHMP opinion for R/R FL

By Dylan Barrett

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Nov 17, 2025

Learning objective: After reading this article, learners will be able to cite a new clinical development in R/R FL.


On November 17, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion and recommendation for the approval of tafasitamab in combination with rituximab + lenalidomide for the treatment of adult patients with relapsed/refractory (R/R) follicular lymphoma (FL) after ≥1 prior line of systemic therapy.1

This decision is based on results from the multicenter, double-blind, placebo-controlled, randomized phase III inMIND trial (NCT04680052).1 The Lymphoma Hub previously reported the primary results from this trial. Patients who received tafasitamab + rituximab + lenalidomide had a median progression-free survival of 22.4 months vs 13.9 months in the placebo + rituximab + lenalidomide arm (hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.32–0.58; p < 0.0001).1 

Tafasitamab + rituximab + lenalidomide was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with R/R FL. 

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