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.
The trial, which enrolled 654 patients, demonstrated that the Minjuvi-led combination significantly extended the duration patients lived without their disease worsening.
Those treated with the new regimen achieved a median progression-free survival of 22.4 months, compared to 13.9 months in the control group.
Statistical analysis showed a hazard ratio of 0.43, representing a substantial reduction in the risk of disease progression.
Incyte’s leadership in Japan characterized the milestone as a critical step in addressing unmet needs for patients who have exhausted earlier lines of therapy.
Beyond the primary efficacy data, an independent review committee confirmed the therapy's benefits, noting that the median progression-free survival for the Minjuvi group had not yet been reached at the time of analysis.
While the treatment was generally well-tolerated, common side effects included respiratory infections, fatigue, and diarrhea.
This regulatory win represents Incyte’s inaugural approval for Minjuvi in the Japanese market, strengthening its global oncology portfolio.