TOKYO (dpa-AFX) - Incyte Biosciences (INCY) in Japan announced on Friday that Japan's Ministry of Health, Labour and Welfare has approved Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma.
The approval was supported by data from the global Phase II L-MIND study and Japan's Phase Ib/II J-MIND trial, which evaluated the therapy in patients ineligible for autologous stem cell transplant.
In the studies, the combination demonstrated strong response rates and durable clinical benefits, while maintaining a manageable safety profile. Common side effects included neutropenia and thrombocytopenia.
The decision marks Minjuvi's second approval in Japan, following its earlier authorization for relapsed or refractory follicular lymphoma. Incyte said the approval expands treatment options for patients facing this aggressive blood cancer.
INCY closed trading on Thursday at $98.22, down $0.77 or 0.78 percent on the Nasdaq.
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