WILMINGTON, Del.--(BUSINESS WIRE)---- $INCY--Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma. ...

Winnie has lived with vitiligo for most of her life and faced related challenges, including hurtful comments and lack of understanding from others about the condition. As part of the partnership, Winnie steps into her past in two new videos, revisiting her childhood and sharing advice for her younger self and others on similar journeys. Dec 2, 2025 9:15 AM Eastern Standard Time Incyte and Winnie Harlow Join Forces to Share Her Personal Vitiligo Story and Spark Conversation and Understanding Share In partner ...

Core Viewpoint - Incyte has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) regarding Minjuvi® (tafasitamab) for the treatment of relapsed or refractory follicular lymphoma (FL) [1] Company Summary - Incyte is advancing its product Minjuvi® (tafasitamab) for patients with relapsed or refractory follicular lymphoma, indicating a significant step in its oncology portfolio [1] - The positive CHMP opinion is a crucial milestone that may lead to expanded market access for Minjuvi® in Europe [1] Industry Summary - The approval process for oncology treatments like Minjuvi® reflects the ongoing demand for effective therapies in the oncology sector, particularly for challenging conditions such as follicular lymphoma [1] - The positive opinion from CHMP may influence competitive dynamics within the oncology market, as companies seek to address unmet medical needs in hematological malignancies [1]

Core Insights - Knight Therapeutics Inc. has launched Minjuvi® (tafasitamab) in Mexico through its affiliate Grupo Biotoscana de Especialidad S.A. de C.V. [1] - Minjuvi® is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) [2][4]. Company Overview - Knight Therapeutics Inc. is a pan-American specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products in Canada and Latin America [12]. - The company entered a supply and distribution agreement with Incyte for exclusive rights to distribute tafasitamab in Latin America [7]. Product Details - Minjuvi® is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, demonstrating a 60% objective response rate (ORR) in clinical trials [4][8]. - The L-MIND trial showed a complete response rate (CR) of 43% and a disease control rate (DCR) of 74% for Minjuvi® in combination with lenalidomide [4]. Clinical Significance - DLBCL is the most common subtype of non-Hodgkin lymphoma, with many patients facing poor prognosis due to refractory disease or relapse [3]. - Approximately 57% of patients responding to Minjuvi® remained in remission at 5 years, highlighting its effectiveness as a treatment option [5]. Regulatory Approval - Minjuvi® received marketing authorization in Mexico based on the L-MIND trial data and was recognized as an orphan medicine by COFEPRIS [4][7]. - The product has also received accelerated approval in the United States and conditional marketing authorization in Europe for similar indications [9].