Incyte Biosciences (INCY) announced that Japan’s Ministry of Health, Labour and Welfare has granted approval for Minjuvi (tafasitamab) in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most prevalent type of non-Hodgkin lymphoma.
The regulatory decision was based on findings from the global Phase II L-MIND trial and Japan’s Phase Ib/II J-MIND study, both of which assessed the treatment’s efficacy in individuals unsuitable for autologous stem cell transplant. Results from these trials highlighted robust response rates and sustained clinical outcomes, with a tolerable safety profile. Frequently reported adverse events included neutropenia and thrombocytopenia.
This marks the second indication for Minjuvi in Japan, following its prior approval for relapsed or refractory follicular lymphoma. The company emphasized that the expanded approval broadens therapeutic choices for patients confronting this aggressive hematologic malignancy.
