INCYte receives Japanese approval for Minjuvi lymphoma drug

Incyte received approval in Japan for its lymphoma drug Minjuvi (pembrolizumab), despite a drop in the company's stock price.

INCY has won Japanese regulatory approval for Minjuvi (tafasitamab) in combination with lenalidomide to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant. The clearance from Japan's Ministry of Health, Labour and Welfare extends the reach of the anti-CD19 antibody into one of the largest oncology markets outside the United States.

The approval was supported by the international Phase II L-MIND study and the Japanese Phase Ib/II J-MIND trial. In J-MIND, the tafasitamab-plus-lenalidomide regimen produced an overall response rate of 71.4%, including a 45.2% complete response rate, in a patient population with limited treatment options. DLBCL is the most common and aggressive subtype of non-Hodgkin lymphoma, and relapsed or refractory cases carry a poor prognosis.

For Incyte, the decision broadens the geographic footprint of a key hematology product and adds an incremental growth lever as the company works to diversify beyond franchise anchor Jakafi. Shares slipped modestly on the news, suggesting the approval was largely anticipated; investors will watch Japanese launch uptake and ongoing trials evaluating tafasitamab in additional lymphoma settings as the larger catalysts.