Japan approves Minjuvi (tafasitamab) plus lenalidomide for adults with relapsed or refractory DLBCL, supported by durable responses from the Phase 2 L-MIND and J-MIND studies.
Written By: Shaik Yasmeen, PharmD
Reviewed By: Pharmacally Editorial Team
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi® (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The approval marks the first authorization in Japan for the tafasitamab-lenalidomide combination in DLBCL and provides a new treatment option for patients whose disease has returned or progressed after prior therapy and who are not eligible for autologous stem cell transplant (ASCT).
The decision was supported by data from the global Phase II L-MIND study and the Japanese Phase Ib/II J-MIND study, both of which demonstrated clinically meaningful and durable responses with the tafasitamab-lenalidomide regimen.
Addressing an Unmet Need in Relapsed DLBCL
DLBCL is the most common form of non-Hodgkin lymphoma and is characterized by aggressive growth of malignant B cells. Although many patients respond to first-line treatment, outcomes remain poor after relapse, particularly among those who cannot undergo stem cell transplantation. The need for effective, non-transplant treatment options remains significant in this setting.
Tafasitamab is a humanized monoclonal antibody that targets CD19, a protein broadly expressed on B cells. The antibody incorporates an engineered Fc domain that enhances immune-mediated tumor cell killing through antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and induction of apoptosis.
L-MIND and J-MIND Data Supported Approval
The approval is primarily based on results from the L-MIND trial (NCT02399085), a single-arm, open-label Phase II study evaluating tafasitamab plus lenalidomide in adults with relapsed or refractory DLBCL who had received one to three prior therapies and were not candidates for ASCT. The study achieved its primary endpoint, demonstrating an overall response rate (ORR) of 58.8%, including a complete response (CR) rate of 41.3% and a partial response (PR) rate of 17.5%.
The durability of benefit was particularly notable. The median duration of response had not been reached after more than 44 months of follow-up, an important finding in a patient population with historically limited long-term treatment success.
Additional evidence came from the Japanese J-MIND trial (NCT04661007), which evaluated the same combination in patients with relapsed or refractory DLBCL previously treated with one to three systemic regimens, including CD20-targeted therapy. The study reported an ORR of 71.4%, with complete responses observed in 45.2% of patients and partial responses in 26.2%. These findings reinforced the efficacy of the regimen in a Japanese patient population.
Manageable Safety Profile
Across both studies, the safety profile was consistent with previous experience. The most commonly reported adverse events included neutropenia and thrombocytopenia. Investigators described the side effects as manageable, supporting the regimen’s favorable benefit-risk profile.
Expanding Treatment Options for Patients
Yasuyuki Ishida, General Manager of Incyte Biosciences Japan, said the approval offers a new treatment option for patients facing relapsed or refractory DLBCL, a disease with historically limited therapeutic choices after initial treatment failure.
For patients who are not candidates for stem cell transplantation, the regimen offers a non-transplant treatment option capable of producing deep and durable responses.
Strengthening Tafasitamab’s Global Presence
The latest approval marks the second regulatory authorization for Minjuvi in Japan. The therapy previously received approval in combination with rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma after at least one prior line of treatment.
With this decision, Japan joins the United States and Europe in expanding access to tafasitamab-based therapy for relapsed or refractory B-cell malignancies. The approval further expands tafasitamab’s global footprint and reinforces the role of CD19-directed immunotherapy across B-cell cancers. As treatment options continue to evolve, the approval strengthens the position of tafasitamab as an important non-transplant therapeutic option for patients with difficult-to-treat lymphoma.
Reference
About the Writer
Shaik Yasmeen (LinkedIn) is a Pharm.D graduate with interests in clinical pharmacy, pharmacovigilance, and medical writing. She has gained experience through hospital clinical postings, patient case reviews, case presentations, and literature evaluation. Passionate about evidence-based healthcare, she is committed to creating accurate and engaging medical content while continuously expanding her professional knowledge.