Ono Pharma Korea and BMS Korea announced on the 22nd that Opdivo (nivolumab) has been additionally approved by the Ministry of Food and Drug Safety as a first-line treatment for urothelial cell carcinoma (UCC).

The new indication is for the first-line treatment of unresectable or metastatic urothelial cell carcinoma in combination with cisplatin and gemcitabine. Patients with unresectable or metastatic urothelial cell carcinoma who have not received prior therapy are eligible to receive the combination treatment.

The approval was based on the results of the Phase III CheckMate-901 study, which compared the use of Opdivo isplatin+gemcitabine combination followed by Opdivo monotherapy with