Ono Pharmaceutical has submitted a supplemental application of OPDIVO Intravenous Infusion, a fully human PD-1 monoclonal antibody in Japan, to expand its use for the treatment of unresectable anaplastic thyroid cancer, for a partial change in approved items of the manufacturing and marketing approval.

This application is based on the results of the Japanese phase 2 investigator-initiated trial (the NAVIGATION study, YCU18001), by the National Cancer Center Hospital East, which evaluated combination therapy in patients with unresectable anaplastic thyroid cancer with OPDIVO and Lenvima, a receptor tyrosine kinase inhibitor discovered by Eisai, that inhibits kinases implicated in pathogenic angiogenesis and tumor growth. The results of this study showed an Objective Response Rate (ORR) of 47.6 percent (95 percent Confidence Interval, 33.4 to 62.3 percent), thus meeting the primary endpoint. In terms of safety, Adverse Events (AEs) were manageable with appropriate measures.

Anaplastic thyroid cancer is a type of thyroid cancer and an epithelial malignant tumor characterised by marked architectural and cytological atypia. Although it is a rare cancer type, with the number of patients in Japan estimated to be approximately 170 to 1,640, the prognosis is poor. While several drugs have been approved for the treatment of unresectable anaplastic thyroid cancer, treatment options remain limited. Standard therapy for anaplastic thyroid cancer has yet to be established, and there is a high need for developing new treatment approaches.

OPDIVO was designated as an orphan drug for the indication of unresectable anaplastic thyroid cancer on May 18, 2026, and is accepted for Priority Review (PR) by the Ministry of Health, Labour and Welfare (MHLW).