Minjuvi Expands European Footprint With Second Approval for Follicular Lymphoma Treatment

2025-12-26 05:04:08

Incyte Corp. (INCY) has secured a significant regulatory win in Europe following the European Commission’s greenlit of Minjuvi—marketed as Monjuvi in the United States—for treating adult patients battling relapsed or refractory follicular lymphoma. The approval marks the company’s second indication for this CD19-targeting monoclonal antibody in the European market, building on the drug’s earlier clearance for diffuse large B-cell lymphoma (DLBCL) in 2021.

The regulatory endorsement comes backed by robust clinical evidence from the Phase 3 inMIND trial, which demonstrated that combining Minjuvi with lenalidomide and rituximab successfully achieved its primary efficacy target of progression-free survival in patients who had exhausted at least one prior systemic therapy regimen. This combination therapy addresses a significant clinical gap, as follicular lymphoma accounts for approximately 30% of non-Hodgkin lymphoma cases globally and represents the most prevalent form of indolent B-cell malignancy.

Minjuvi, the commercial name for tafasitamab-cxix, functions as a humanized Fc-modified cytolytic antibody engineered to target CD19 on malignant B cells. Incyte secured exclusive global development and commercialization rights to the molecule through its licensing agreement with Xencor, Inc. The therapeutic now carries dual approvals in the U.S. market, available both as monotherapy combined with lenalidomide for DLBCL and as part of the three-drug regimen for follicular lymphoma.

The market reception has been notably positive. During the third quarter of 2025, Minjuvi/Monjuvi revenues surged 34%, reaching $41.99 million compared to $31.44 million in the corresponding prior-year period. Stock performance reflected investor confidence, with INCY closing Wednesday’s trading session at $97.63, up 0.62% from the previous close.

The European Commission’s decision follows the Committee for Medicinal Products for Human Use (CHMP) favorable recommendation issued last month, reinforcing the regulatory pathway for expanded follicular lymphoma treatment options across key markets.

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