Minjuvi Wins European Green Light For Follicular Lymphoma Combination Therapy

Incyte Corp. disclosed Thursday that European Commission regulators have greenlit its CD19-targeting therapeutic Minjuvi alongside lenalidomide and rituximab to address relapsed or refractory follicular lymphoma patients who have undergone prior systemic treatment. The approval encompasses Grade 1-3a disease presentations and marks an expansion of the immunotherapy’s indication portfolio in the European market.

The regulatory milestone follows a favorable recommendation issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use last month, which supported the triplet regimen approach. Supporting this decision was robust efficacy data derived from the Phase 3 inMIND clinical trial, which successfully demonstrated that the combination achieved its predetermined progression-free survival endpoint in this patient population.

Understanding Follicular Lymphoma and Treatment Landscape

Follicular lymphoma represents the predominant slow-growing hematologic malignancy originating from B-cell lineage, accounting for approximately 30% of global non-Hodgkin lymphoma diagnoses. This indolent disease category necessitates novel therapeutic strategies, particularly for patients whose disease becomes resistant to initial interventions.

Tafasitamab-cxix, the active pharmaceutical ingredient in Minjuvi, functions as a humanized monoclonal antibody engineered with modified Fc properties to enhance cytolytic activity against CD19-expressing B cells. Incyte maintains exclusive worldwide development and commercialization rights to this asset, originally licensed from Xencor, Inc.

Expanding Clinical and Commercial Footprint

The European approval strengthens Minjuvi’s therapeutic positioning in lymphoid malignancies. The drug previously received EC authorization in 2021 for relapsed or refractory diffuse large B-cell lymphoma when paired with lenalidomide alone. In the United States, where the product carries the brand designation Monjuvi, it is currently approved for dual indications: lenalidomide monotherapy for DLBCL, and the current triplet combination for follicular lymphoma applications.

Commercial momentum appears robust, with third-quarter 2025 revenue reflecting a 34% year-over-year surge to $41.99 million, compared to $31.44 million in the equivalent prior-year period. INCY equity closed Wednesday trading at $97.63, reflecting a modest 0.62% advance.