Bristol Myers Squibb (BMS; NYSE: BMY) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 drug Opdivo (nivolumab) in combination with cisplatin and gemcitabine. This approval is for a first-line treatment of unresectable or metastatic urothelial carcinoma (UC). The Opdivo/chemo combination is now the first and only immunotherapy approved for the first-line treatment of advanced UC in China, with Opdivo being the sole PD-1 inhibitor with approved indications covering early adjuvant therapy and advanced first-line treatment for UC in the country.
Phase III CheckMate-901 Study Supports Approval
The approval is supported by the results of the Phase III CheckMate-901 study, which is the world’s first Phase III clinical study of an immune combination therapy as a first-line UC treatment. The study demonstrated efficacy significantly superior to standard cisplatin chemotherapy. Moreover, the study showed significant benefits to patients in terms of overall survival (OS) and progression-free survival (PFS).- Flcube.com
