Opdivo and Cabometyx combination clocks Japanese approval
Approval has been granted for the combination of Opdivo (nivolumab) intravenous infusion and Cabometyx (cabozantinib s-malate) tablets in Japan for the treatment of unresectable or metastatic renal cell carcinoma, for a partial change in approved items of the manufacturing and marketing approval.
Ono Pharmaceutical’s (TYO: 4528) Opdivo is a PD-1 immune checkpoint inhibitor with multi-billion dollar annual sales. Cabometyx, meanwhile, is a tyrosine kinase inhibitor which fellow Japanese firm Takeda (TYO: 4502) has licensed from California-based Exelixis (Nasdaq: EXEL) for development and commercialization in Japan.
It is estimated that about 25,000 new cases of kidney cancer are diagnosed per year in Japan and approximately 8,550 deaths per year result from this disease in the Asian country.
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