Ono Pharmaceutical Co. announced that Ono Pharma Taiwan Co., a Taiwanese subsidiary of Ono, received the additional approval of Opdivo Intravenous Infusion, an anti-PD-1 antibody, on January 14 from the Taiwan Food and Drug Administration in Taiwan, in combination with ipilimumab, for the treatment of adult patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer. The approval is based on the results from the CheckMate-8HW study.
Opdivo as a single agent, or in combination with Yervoy, was previously granted accelerated approval in MSI-High/dMMR CRC adult patients that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. The company noted that the TFDA decision converts this second-line indication to full approval for Opdivo monotherapy, and expands the indication for Opdivo plus Yervoy into the first-line setting based on the CheckMate-8HW study.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.