Wilmington, Delaware — November 17, 2025 — Leads & Copy — Incyte’s Minjuvi® (tafasitamab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending its approval in combination with lenalidomide and rituximab for treating adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one prior line of systemic therapy.
According to Lee Heeson, Executive Vice President and Head of Incyte International, if approved, this combination would mark the first CD19- and CD20-dual-targeted immunotherapy for European patients with relapsed or refractory FL. The recommendation is based on results from the Phase 3 inMIND clinical trial, which demonstrated Minjuvi’s ability to improve progression-free survival (PFS) for patients.
The CHMP’s positive opinion stems from data gathered during the Phase 3 inMIND trial, which assessed the effectiveness and safety of Minjuvi when used with rituximab and lenalidomide in 548 adult patients diagnosed with relapsed or refractory FL. The trial’s findings, presented at the 2024 American Society of Hematology (ASH) Annual Meeting, the 2025 European Hematology Association (EHA) Congress, and the 2025 International Conference on Malignant Lymphoma (ICML), indicated that Minjuvi, in conjunction with rituximab and lenalidomide, achieved its primary endpoint.
Data showed that the combination significantly improved PFS compared to a placebo combined with lenalidomide and rituximab. Patients treated with Minjuvi, rituximab, and lenalidomide experienced a median PFS of 22.4 months (95% CI, 19.2-not evaluable [NE]), as assessed by investigators, versus 13.9 months (95% CI, 11.5-16.4) in the control group (hazard ratio [HR]: 0.43 [95% CI, 0.32-0.58]; P<0.0001). An Independent Review Committee (IRC) also evaluated PFS, with results consistent with those reported by investigators. The median PFS by IRC was not reached (95% CI, 19.3-NE) in the Minjuvi group compared to 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41 [95% CI, 0.29-0.56]).
Minjuvi demonstrated a well-tolerated and manageable safety profile, consistent with safety observed when tafasitamab is added to lenalidomide and rituximab. The most frequently reported adverse reactions (≥ 20%) among Minjuvi recipients, excluding laboratory abnormalities, included respiratory tract infections (such as COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.
Follicular lymphoma (FL) is the most common indolent form of B-cell non-Hodgkin lymphoma (NHL), accounting for approximately 30% of NHL cases worldwide. The disease is considered incurable, with patients often relapsing after initial treatment, which results in a progressively worsening prognosis with each recurrence. There remains an unmet need for additional treatment options for relapsed or refractory FL.
According to Stefano Luminari, M.D., Professor of Oncology, University of Modena and Reggio Emilia, Italy, and inMIND study investigator, the approval of Minjuvi would introduce an important second-line chemotherapy-free alternative for European patients with relapsed or refractory FL after one prior treatment line, as it has demonstrated a significant reduction in the risk of disease progression across a wide patient demographic.
The European Commission is currently reviewing the CHMP opinion and has the authority to approve centrally authorized products in the EU. Approval would mark Minjuvi’s second indication, having previously been approved by the European Commission in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
The global, double-blind, randomized, placebo-controlled Phase 3 inMIND study (NCT04680052) evaluated the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide compared with placebo in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma (FL) Grade 1 to 3a or relapsed or refractory nodal, splenic or extranodal marginal zone lymphoma (MZL). The study enrolled a total of 654 adults (age ≥18 years).
The study’s primary endpoint was progression-free survival (PFS) by investigator assessment in the FL population, while the key secondary endpoints were PFS in the overall population, as well as positron emission tomography complete response (PET-CR) and overall survival (OS) in the FL population. More information about the study can be found at https://clinicaltrials.gov/study/NCT04680052.
Minjuvi® (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody that incorporates an XmAb® engineered Fc domain. Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).
In Europe, Minjuvi received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT.
Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded.
For more information, see the Minjuvi SmPC.
Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.
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Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential for tafasitamab, in combination with rituximab and lenalidomide, to become a new treatment option for relapsed or refractory follicular lymphoma, contain predictions, estimates, and other forward-looking statements.
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Source: Incyte
