Press release
Incyte Japan Announces Approval of Minjuvi® (tafasitamab) in Combination with Rituximab and Lenalidomide for the Treatment of Relapsed or Refractory Follicular Lymphoma
TOKYO--(BUSINESS WIRE)-- Incyte Biosciences Japan G.K. today announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Minjuvi®
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[{"type":"text","content":" TOKYO--(BUSINESS WIRE)--\nIncyte Biosciences Japan G.K. today announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Minjuvi® (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).\n\n\n“Today's approval of Minjuvi in combination with rituximab and lenalidomide marks a significant milestone as the first dual-targeted CD19 and CD20 immunotherapy combination for relapsed or refractory FL in Japan,” said Yasuyuki Ishida, General Manager, Incyte Biosciences Japan. “By improving progression-free survival, Minjuvi 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.”\n\n\nThe approval is based on the pivotal Phase 3 inMIND trial, which enrolled 654 adult patients, including patients based in Japan. The study demonstrated that Minjuvi combined with rituximab and lenalidomide significantly improved progression-free survival (PFS) compared to the control arm.1 Patients receiving Minjuvi achieved a median PFS of 22.4 months, significantly longer than the 13.9 months observed in the control arm.1 The hazard ratio was 0.43, with a p-value of less than 0.0001, indicating a substantial reduction in the risk of progression.1\n\n\nAssessments by an Independent Review Committee confirmed these results, with median PFS not reached in the Minjuvi group, compared to 16.0 months in the placebo group.1 Minjuvi was generally well-tolerated, with respiratory infections, diarrhea and fatigue among the most common adverse reactions.1\n\n\nFL is the second most common, slow-growing form of B-cell non-Hodgkin lymphoma (NHL) in Japan, accounting for 13.5% of all NHL types.2 It is considered incurable, and approximately 20% of patients experience progression or relapse within the first two years of starting treatment. This early progression (POD24) is associated with a significantly poorer prognosis, with only 34–50% of these patients being alive at five years.3,4,5 Despite advances in treatment, there remains a significant unmet need for additional options for relapsed or refractory FL.\n\n\nThis is the first regulatory approval for Minjuvi in Japan.\n\n\nAbout i...