Double European Approval Marks Milestone for Incyte's Follicular B Cell Lymphoma Treatment

2025-12-26 01:27:09

Abstract generation in progress

Incyte Corp. (INCY) has achieved a significant regulatory milestone with the European Commission’s approval of Minjuvi (tafasitamab-cxix) combined with lenalidomide and rituximab for treating adults with relapsed or refractory follicular lymphoma. This marks the company’s second European green light for the immunotherapy in this indication, following earlier backing from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Clinical Validation and Disease Significance

The regulatory decision was grounded in robust Phase 3 inMIND trial data demonstrating that the triple-drug combination achieved its primary endpoint of progression-free survival in patients with Grade 1-3a follicular lymphoma who had experienced prior treatment failure. Follicular lymphoma represents a particularly challenging disease segment, accounting for approximately 30% of global non-Hodgkin lymphoma cases. As a slow-growing malignancy originating in B cells—a critical component of the immune system—this follicular b cell lymphoma subtype has historically been difficult to manage, especially in patients resistant to initial therapies.

Mechanism and Development Trajectory

Minjuvi functions as a humanised, Fc-modified monoclonal antibody specifically engineered to target CD19, a surface marker prevalent on B cell malignancies. This targeted approach has proven effective across multiple B-cell lymphoma indications. Incyte secured exclusive global development and commercialisation rights to tafasitamab from Xencor, Inc., enabling the company to expand the drug’s therapeutic footprint.

Expanding Market Presence

The company markets the therapeutic under the brand name Monjuvi in the United States, where it carries approvals for both diffuse large B-cell lymphoma in combination with lenalidomide, and follicular lymphoma in triple combination therapy. Financial performance reflects strong market traction: Minjuvi/Monjuvi quarterly revenues reached $41.99 million in Q3 2025, representing 34% growth year-over-year from $31.44 million in the comparable 2024 period. This trajectory underscores increasing clinical adoption and patient access across major markets.

INCY shares closed Wednesday trading at $97.63, advancing 0.62% on the regulatory development.

This page may contain third-party content, which is provided for information purposes only (not representations/warranties) and should not be considered as an endorsement of its views by Gate, nor as financial or professional advice. See Disclaimer for details.