25 August 2021 - Ono Pharmaceutical and Takeda today announced that the companies have received an approval for combination therapy of Ono’s Opdivo (nivolumab) and Takeda’s Cabometyx (cabozantinib s-malate) tablets which Takeda has licensed from Exelixis, in combination therapy for the treatment of unresectable or metastatic renal cell carcinoma, for a partial change in approved items of the manufacturing and marketing approval.
This approval is based on results from the global, multi-center, randomised, open-label Phase 3 CheckMate-9ER study, evaluating Opdivo and Cabometyx combination therapy versus sunitinib alone in patients with previously untreated advanced or metastatic renal cell carcinoma.