Tafasitamab-cxix (Minjuvi) in combination with rituximab (Rituxan) and lenalidomide (Revlimid) has been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of adult patients with relapsed or refractory follicular lymphoma, representing the agent’s first regulatory approval in Japan.1
The regulatory decision was supported by data from the phase 3 inMIND trial (NCT04680052), which demonstrated improved progression-free survival (PFS) with tafasitamab plus rituximab and lenalidomide vs the control arm of placebo plus rituximab and lenalidomide, with a median PFS of 22.4 months compared with 13.9 months, respectively (HR, 0.43; P < .0001). Independent review committee assessment corroborated these findings, showing a median PFS that was not reached in the tafasitamab arm vs 16.0 months in the placebo arm.
“[This] approval of [tafasitamab] in combination with rituximab and lenalidomide marks a significant milestone as the first dual-targeted CD19 and CD20 immunotherapy combination for relapsed or refractory follicular lymphoma in Japan,” Yasuyuki Ishida, general manager of Incyte Biosciences Japan, shared in a news release. “By improving PFS, [tafasitamab] offers a chemotherapy-free option for eligible patients with relapsed or refractory disease. This approval underscores our commitment to bridging critical treatment gaps to patients and families affected by this challenging disease in Japan.”
Japan Gains Approval of Tafasitamab-Based Triplet in R/R Follicular Lymphoma
- Japan’s Ministry of Health, Labour and Welfare approved tafasitamab plus rituximab and lenalidomide for adult patients with relapsed/refractory follicular lymphoma.
- This approval was supported by data from the inMIND trial showing a median PFS of 22.4 months vs 13.9 months (HR, 0.43; P < .0001). The independent review committee–assessed median PFS was not reached vs 16.0 months, respectively.
- Safety was generally consistent; common AEs included respiratory infections, diarrhea, and fatigue.
How was the inMIND study designed to evaluate tafasitamab plus rituximab/lenalidomide in relapsed/refractory FL?
inMIND is a global, double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of tafasitamab in combination with rituximab and lenalidomide vs placebo plus rituximab and lenalidomide in adults at least 18 years of age with relapsed or refractory follicular lymphoma grade 1 to 3a; or relapsed or refractory nodal, splenic, or extranodal marginal zone lymphoma (MZL). In total, 654 patients were enrolled.1,2
The primary end point is progression-free survival (PFS) by investigator assessment in the follicular lymphoma population. Key secondary end points include PFS, overall survival (OS), and complete response (CR) rate in the overall population, as well as CR rate and OS in the follicular lymphoma population.
Eligible patients were randomly assigned 1:1 to receive up to 12, 28-day cycles of intravenous (IV) tafasitamab at 12 mg/kg on days 1, 8, 15, and 22 of cycles 1 to 3, then on days 1 and 15 of cycles 4 to 12; or placebo.3 Patients in both arms also received oral lenalidomide at 20 mg per day on days 1 to 21 of cycles 1 to 12 and IV rituximab at 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2 to 5.
What additional safety signals were observed with the combination?
Regarding safety, serious adverse effects (AEs) were reported in 33% of patients who received the tafasitamab-based regimen, including a 24% rate of serious infections.4 The prescribing information for tafasitamab cites warnings and precautions for infections, infusion-related reactions, and myelosuppression.
What additional global regulatory milestones has tafasitamab plus rituximab and lenalidomide secured for relapsed/refractory follicular lymphoma?
On June 18, 2025, the US FDA approved the combination for the same indication, and the European Commission granted approval to the combination on December 18, 2025, for the same indication.4,5Both decisions were supported by findings from inMIND.
What is the recommended tafasitamab dosing schedule in follicular lymphoma?
Tafasitamab in this indication is administered at 12 mg/kg as an IV infusion for up to 12 cycles in combination with lenalidomide and rituximab.4
References
- 1.Incyte Japan announces approval of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for the treatment of relapsed or refractory follicular lymphoma. Incyte. News Release. December 22, 2025. Accessed January 2, 2026. https://investor.incyte.com/news-releases/news-release-details/incyte-japan-announces-approval-minjuvir-tafasitamab-combination
- 2.A phase 3 study to assess efficacy and safety of tafasitamab plus lenalidomide and rituximab compared with placebo plus lenalidomide and rituximab in patients with relapsed/refractory (R/R) follicular lymphoma or marginal zone lymphoma. (InMIND). ClinicalTrials.gov. Updated December 22, 2025. Accessed January 2, 2026. https://clinicaltrials.gov/study/NCT04680052
- 3.Sehn LH, Hübel K, Luminari S, et al. Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. Lancet. Published online December 5, 2025. doi:10.1016/S0140-6736(25)01778-7
- FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma. FDA. June 18, 2025. Accessed January 2, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tafasitamab-cxix-relapsed-or-refractory-follicular-lymphoma
- Incyte announces European Commission approval of Minjuvi (tafasitamab) for the treatment of relapsed or refractory follicular lymphoma. News release. Incyte. December 17, 2025. Accessed January 2, 2025. https://investor.incyte.com/news-releases/news-release-details/incyte-announces-european-commission-approval-minjuvir
![[177Lu]Lu-D-Dan-Phe-PSMA in mCRPC: ©pikovit - stock.adobe.com](https://cdn.sanity.io/images/0vv8moc6/onclive/d71414d0f65f6c3fef8831090bab6d436c1497ec-1280x720.png?w=350&fit=crop&auto=format)
