Incyte Receives Second European Nod for Minjuvi in Follicular Lymphoma

Incyte Corporation (INCY) has secured its second regulatory greenlight from the European Commission, this time clearing Minjuvi (tafasitamab-cxix) for a broader patient population. The immunotherapy, administered alongside lenalidomide and rituximab, is now authorized for treating adults with relapsed or refractory follicular lymphoma (Grade 1-3a) who have undergone at least one prior systemic therapy regimen.

Clinical Validation Drives Regulatory Win

The European regulatory nod builds on compelling Phase 3 inMIND trial data demonstrating that the triple-drug combination successfully achieved its primary efficacy objective of extending progression-free survival. Prior to the European Commission’s formal decision, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had already signaled support through its positive opinion, setting the stage for this approval milestone.

Understanding Follicular Lymphoma and Treatment Landscape

Follicular lymphoma represents the most prevalent slow-growing hematologic malignancy originating from B cells, accounting for approximately 30% of all non-Hodgkin lymphoma diagnoses worldwide. This patient population has historically faced limited treatment options after initial therapy failure, making the expanded approval particularly significant for medical practitioners seeking effective relapsed/refractory options.

Product Portfolio Expansion

Minjuvi, the humanized Fc-modified CD19-targeting monoclonal antibody licensed from Xencor, Inc., now carries approvals for multiple lymphoma indications across major markets. The European approval marks the drug’s second distinct indication in the region, following its 2021 clearance for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with lenalidomide. In the United States, the same therapeutic is marketed as Monjuvi, where it maintains approvals for both DLBCL monotherapy applications and the follicular lymphoma indication.

Strong Commercial Momentum

The commercial trajectory remains robust, with third-quarter 2025 sales reaching $41.99 million, representing a 34% year-over-year increase from $31.44 million in the comparable prior-year period. INCY shares closed the previous trading session at $97.63, reflecting a modest 0.62% gain that day.