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Tafasitamab + lenalidomide + rituximab approved by Japan’s MHLW for R/R FL
On December 22, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) announced approval for tafasitamab in combination with rituximab + lenalidomide for adult patients with relapsed/refractory (R/R) follicular lymphoma (FL).1
This approval is based on results from the randomized, double-blind, placebo-controlled, phase III inMIND trial (NCT04680052), which were previously reported by the Lymphoma Hub.1 This trial enrolled 654 adult patients with R/R FL Grade 1–3a or R/R marginal zone lymphoma, including patients based in Japan.1 Median progression-free survival (PFS) was superior in patients receiving tafasitamab + rituximab + lenalidomide vs patients receiving placebo + rituximab + lenalidomide (22.4 months vs 13.9 months; hazard ratio [HR], 0.43; p < 0.0001).1 Independent Review Committee (IRC) assessments corroborated these findings, showing that median PFS was not reached in the tafasitamab + rituximab + lenalidomide group vs 16.0 months in the placebo group.1 Tafasitamab was generally well tolerated, with respiratory infections, diarrhea, and fatigue reported as the most common adverse events.1
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