Incyte Biosciences Japan G.K. has secured regulatory clearance from Japan’s Ministry of Health, Labour and Welfare for Minjuvi, marking the first time a dual-targeted CD19 and CD20 immunotherapy combination has been authorized for patients with follicular lymphoma in the country.
The approval specifically covers the use of Minjuvi, known chemically as tafasitamab, in combination with rituximab and lenalidomide for adults suffering from relapsed or refractory forms of the disease.
The decision introduces a chemotherapy-free alternative to a market where follicular lymphoma remains a significant challenge, accounting for roughly 13.5% of all non-Hodgkin lymphoma cases in Japan.
While the disease is characterized by slow growth, it is currently considered incurable.
Clinical data suggests that approximately 20% of patients relapse within two years of initial treatment, a progression that typically signals a poor prognosis with five-year survival rates hovering between 34% and 50%.
Central to the Ministry's approval were results from the pivotal Phase 3 inMIND trial, a global study that included participants from Japan.