Incyte announced that its antibody‑drug conjugate Minjuvi (tafasitamab) has received approval in Japan for use in combination with rituximab and lenalidomide to treat relapsed or refractory follicular lymphoma. The same announcement confirmed that the company’s checkpoint inhibitor Zynyz (retifanlimab) has been approved for first‑line treatment of advanced squamous cell carcinoma of the anal canal (SCAC).
The Japanese oncology market is valued at several billion dollars, and follicular lymphoma accounts for 13.5% of all non‑Hodgkin lymphoma cases in the country. Advanced anal cancer represents 16‑24% of anal canal cancers, a niche but growing segment. In the follicular lymphoma space, existing therapies include rituximab, obinutuzumab, and bendamustine, while SCAC has traditionally been managed with chemoradiation; Zynyz is the first PD‑1 inhibitor approved as a first‑line therapy for this indication.
These approvals broaden Incyte’s product portfolio beyond its core JAKAFI franchise and position the company to capture a share of the Japanese market. The Minjuvi approval introduces the first dual‑targeted CD19/CD20 antibody‑drug conjugate combination for relapsed or refractory follicular lymphoma, while Zynyz offers a novel first‑line option for a disease with limited treatment choices. Management estimates that Zynyz could add several hundred million dollars to the company’s top line, and Minjuvi is expected to generate additional revenue as the Japanese market adopts the new combination therapy.
Yasuyuki Ishida, General Manager of Incyte Biosciences Japan G.K., said the Zynyz approval “is a significant milestone for patients with advanced anal cancer in Japan – the first and only first‑line treatment for SCAC.” He added that the Minjuvi approval “marks a significant milestone as the first dual‑targeted CD19 and CD20 immunotherapy combination for relapsed or refractory follicular lymphoma in Japan.”
The regulatory success in Japan demonstrates Incyte’s ability to navigate international pathways and may accelerate future launches in other regions. By securing approvals in a market with high unmet need and a sizable oncology spend, the company is poised to diversify its revenue streams and strengthen its global oncology presence.
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