The European Commission (EC) has approved Incyte’s Minjuvi (tafasitamab) in conjunction with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) who have received a minimum of one systemic therapy line.
FL is the most common slow-growing B-cell non-Hodgkin lymphoma form.
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Minjuvi is a humanised, fragment crystallisable-modified cytolytic monoclonal antibody targeting cluster of differentiation 19.
The EC approval follows the positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products (CHMP) for Human Use in November 2025.
It is the second indication for the therapy in the European Union. Previously, it received EC approval for use in conjunction with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma.
The decision from the European regulator is supported by the outcomes from the Phase III inMIND trial, which assessed the safety and efficacy of Minjuvi combined with rituximab and lenalidomide in those with relapsed or refractory FL.
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By GlobalDataThe trial demonstrated that the combination achieved its primary goal, showing an improvement in progression-free survival compared to placebo with lenalidomide and rituximab.
The company licenses exclusive global development and commercialisation rights to tafasitamab from Xencor.
Incyte CEO and president Bill Meury stated: “The EC approval of Minjuvi addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory FL.
“Historically, FL patients have had limited treatment options in the second-line setting, and we are proud to drive this important advancement for the lymphoma community as we seek to deliver innovative medicines for patients with cancer.”
In the US, Monjuvi (tafasitamab-cxix) has secured Food and Drug Administration approval in conjunction with lenalidomide and rituximab for adults with relapsed or refractory FL.
In February 2025, Incyte and Genesis Therapeutics announced a strategic partnership focused on the research, discovery, and development of new small-molecule medicines.
