Tafasitamab combo approved in Japan for relapsed, refractory DLBCL

Japan’s Ministry of Health, Labour and Welfare has approved tafasitamab (Minjuvi) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, according to Incyte Biosciences Japan G.K, the manufacturer of the drug. The regulatory approval specifically targets patients who are ineligible for an autologous stem cell transplant.

The clinical approval was based on data from the international phase 2 L-MIND trial and the domestic phase 1b/2 J-MIND trial in Japan. In the international study, patients treated with the tafasitamab combination achieved an overall response rate of 58.8% with a 41.3% complete response rate, according to a press release from the company.

The domestic Japanese study demonstrated an overall response rate of 71.4% and a 45.2% complete response rate, with the main adverse events reported across the clinical programs included neutropenia and thrombocytopenia.

This is the second approval for tafasitamab in Japan, following its previous approval for adult patients with relapsed or refractory follicular lymphoma.