European Regulators Recommend Approval of Incyte's Minjuvi for Relapsed Follicular Lymphoma
Key Insights
The European Medicines Agency (search)'s Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (search) after at least one prior therapy.
Phase 3 inMIND trial results demonstrated statistically significant improvement in progression-free survival, with patients achieving median PFS of 22.4 months compared to 13.9 months in the control arm (HR: 0.43, P<0.0001).
If approved by the European Commission, Minjuvi would represent the first CD19 (search)- and CD20 (search)-dual-targeted immunotherapy for European patients with relapsed or refractory follicular lymphoma (search).
Incyte Corporation announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (search) has issued a positive opinion recommending approval of Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for treating adult patients with relapsed or refractory follicular lymphoma (search) (Grade 1-3a) after at least one line of systemic therapy.
Breakthrough Dual-Targeted Immunotherapy
"If approved, Minjuvi in combination with rituximab and lenalidomide will represent the first CD19 (search)- and CD20 (search)-dual-targeted immunotherapy for patients in Europe living with relapsed or refractory FL," said Lee Heeson, Executive Vice President and Head of Incyte International. The positive CHMP opinion represents an encouraging step in advancing treatments that address critical gaps for patients with this challenging malignancy.
Phase 3 Trial Demonstrates Significant Efficacy
The positive recommendation is based on data from the Phase 3 inMIND trial, which evaluated the efficacy and safety of Minjuvi in combination with rituximab and lenalidomide in 548 adult patients with relapsed or refractory follicular lymphoma (search). The global, double-blind, randomized, placebo-controlled study enrolled a total of 654 adults aged 18 years and older.
Results presented at major medical conferences including the 2024 American Society of Hematology Annual Meeting, 2025 European Hematology Association Congress, and 2025 International Conference on Malignant Lymphoma showed that the combination met its primary endpoint with statistically significant and clinically meaningful improvement in progression-free survival.
Patients receiving Minjuvi in combination with rituximab and lenalidomide achieved a median progression-free survival by investigator assessment of 22.4 months (95% CI, 19.2-not evaluable) compared to 13.9 months (95% CI, 11.5-16.4) in the control arm, representing a hazard ratio of 0.43 (95% CI, 0.32-0.58; P<0.0001).
Independent Review Committee assessment confirmed these results, with median PFS not reached (95% CI, 19.3-NE) in the Minjuvi group versus 16.0 months (95% CI, 13.9-21.1) in the placebo group (HR: 0.41, 95% CI, 0.29-0.56).
Manageable Safety Profile
Minjuvi demonstrated a well-tolerated and manageable safety profile. Safety and tolerability were comparable with the addition of tafasitamab to lenalidomide in combination with rituximab. The most common adverse reactions (≥20%) in recipients of Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhea, rash, fatigue, constipation, musculoskeletal pain and cough.
The most common adverse reactions overall were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%).
Addressing Significant Unmet Medical Need
Follicular lymphoma (search) is the most common slow-growing form of B-cell non-Hodgkin lymphoma (search), representing about 30% of NHL cases globally. The disease is considered incurable, with patients frequently relapsing after initial therapy and experiencing a progressively worsening prognosis with each recurrence. Despite advances in treatment, there remains a significant unmet need for additional options for relapsed or refractory FL, with 2-4 out of every 100,000 people affected in Western countries.
"In Europe, patients with relapsed or refractory FL after one prior treatment line currently receive a limited set of treatment options in the second-line setting," said 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 which has demonstrated a significant reduction in the risk of disease progression across a wide patient demographic."
Mechanism of Action and Regulatory Status
Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19 (search) targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanisms including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.
The CHMP opinion is now being reviewed by the European Commission, which has the authority to grant approval for all centrally authorized products in the EU. If approved, this would mark the second indication for Minjuvi, which was previously approved by the European Commission in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma (search).
In the United States, Monjuvi (tafasitamab-cxix) is already approved by the FDA in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (search), as well as for relapsed or refractory diffuse large B-cell lymphoma (search) in patients not eligible for autologous stem cell transplant.