Incyte Biosciences Japan G.K., part of global biopharmaceutical company Incyte (Nasdaq:INCY), 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).

This approval is supported by data from the international Phase II L-MIND trial and the Japanese Phase Ib/II J-MIND trial, which evaluated the regimen in patients with relapsed or refractory DLBCL who were not eligible for autologous stem cell transplant.

In the L-MIND study, the overall response rate was 58.8%, including a complete response rate of 41.3% and a partial response rate of 17.5%. In the J-MIND trial, the overall response rate was 71.4%, with complete and partial response rates of 45.2% and 26.2%, respectively. The main adverse events were neutropenia and thrombocytopenia.

Incyte said that, overall, Minjuvi in combination with lenalidomide demonstrated a clinically meaningful response with manageable side effects.

The approval marks the second regulatory authorisation for Minjuvi in Japan. The therapy was previously approved in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma.