Ono Pharmaceutical and Bristol-Myers Squibb have announced a supplemental application in Japan for Ono’s Opdivo® and BMS’s Yervoy® in combination therapy, to expand its approved use to the treatment of unresectable hepatocellular carcinoma (HCC).
Ono’s 2011 grant to BMS of commercialisation rights for Opdivo® excluded Japan, South Korea and Taiwan, where Ono retained all rights. In July 2014, Ono and BMS agreed to jointly develop and commercialise multiple immunotherapies as single agent and combination regimens for cancer in Japan, South Korea and Taiwan.
Previous approvals for combination therapies for HCC include Tuoyi® (toripalimab) with bevacizumab (July 2024) and Tyvyt® (sintilimab) with Byvasda® (bevacizumab) (June 2021), both in China.
The combination of Opdivo® and Yervoy® is also the subject of an application by BMS in Australia in respect of unresectable malignant mesothelioma