Japan-based Ono Pharmaceutical Co., Ltd. announced on Wednesday that Ono Pharma Taiwan Co., Ltd. (OPTW), ONO's Taiwanese subsidiary, received the additional approval for Opdivo(R) (nivolumab) Intravenous Infusion, a human anti-human PD-1 monoclonal antibody, on 17 May 2022 in Taiwan from the Taiwan Food and Drug Administration (TFDA) for the treatment of previously untreated or advanced renal cell carcinoma (RCC) in combination with cabozantinib.

This approval is based on the result from the global, multi-centre, randomised, open-label Phase 3 CheckMate -9ER study, evaluating Opdivo and cabozantinib combination therapy versus sunitinib alone in patients with previously untreated advanced or metastatic RCC.

The company said that in this study, Opdivo and cabozantinib combination therapy demonstrated a significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent central review (BICR), compared to sunitinib alone at the final analysis, as well as the secondary endpoints of overall survival (OS) and objective response rate (ORR) as assessed by the BICR. The safety profiles of Opdivo and cabozantinib combination therapy observed in the study were consistent with the previously reported safety profile of each product.