Written By: Pharmacally Medical News Desk
Incyte has announced that the European Commission (EC) has approved Minjuvi® (tafasitamab) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). This decision expands the therapeutic role of tafasitamab in Europe and marks an important regulatory milestone for patients whose disease has progressed after prior lines of therapy.
Bill Meury, President and Chief Executive Officer of Incyte, highlighted that the European Commission approval of Minjuvi fills an important treatment gap for patients with relapsed or refractory follicular lymphoma in Europe. He emphasized that Minjuvi offers a first-of-its-kind, chemotherapy-free option in the second-line setting, reflecting Incyte’s commitment to advancing innovative cancer therapies for the lymphoma community.
What is Minjuvi® (tafasitamab)?
Minjuvi is a humanized Fc-engineered monoclonal antibody targeting CD19, a protein broadly expressed on malignant B cells. Through its engineered Fc region, tafasitamab is designed to enhance immune-mediated mechanisms such as antibody-dependent cellular cytotoxicity and phagocytosis, while also directly inducing tumor cell death. CD19 has long been recognized as a validated target in B-cell malignancies, making tafasitamab a rational therapeutic option in follicular lymphoma.
Clinical Evidence
The European Commission approval is based on results from the Phase 3 inMIND trial, which evaluated Minjuvi in combination with rituximab and lenalidomide in patients with relapsed or refractory follicular lymphoma. The study met its primary endpoint, demonstrating a clinically meaningful improvement in progression-free survival compared with lenalidomide and rituximab alone. Patients treated with the Minjuvi-based combination experienced longer disease control, with a clear reduction in the risk of disease progression or death. Progression-free survival outcomes assessed by both investigators and an independent review committee were consistent, supporting the robustness of the efficacy findings.
Minjuvi was generally well tolerated in the Phase 3 study, with a safety profile consistent with the known effects of tafasitamab, lenalidomide, and rituximab. No new safety signals were observed with the addition of Minjuvi to the combination regimen. The most common adverse reactions included infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain, and cough.
This approval applies across all EU member states, as well as the European Economic Area, ensuring broad access to this treatment option within Europe.
Stefano Luminari, M.D., Professor of Oncology, University of Modena and Reggio Emilia, Italy, and inMIND Study Investigator, underscored the clinical significance of the approval for a complex and incurable disease. He noted that Minjuvi, when combined with lenalidomide and rituximab, introduces the first dual CD19- and CD20-targeted immunotherapy for follicular lymphoma in Europe, with demonstrated benefits in reducing the risk of disease progression, including in patients with high-risk disease.
Follicular Lymphoma
Follicular lymphoma is the most common form of indolent non-Hodgkin lymphoma. Although many patients initially respond to treatment, the disease is characterized by repeated relapses and increasing resistance over time. For patients with relapsed or refractory disease, especially after multiple prior therapies, treatment options become limited and outcomes remain suboptimal. There has been a clear need for novel, targeted approaches that can deliver durable responses with a manageable safety profile.
References
Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma, 17 December 2025, https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-minjuvir
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. (InMIND), ClinicalTrials.gov ID NCT04680052, https://clinicaltrials.gov/study/NCT04680052