Important new FDA approval for BMS’ Opdivo combo

8 March 2024

The US Food and Drug Administration (FDA) yesterday approved Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.

Opdivo is already one of US pharma major Bristol Myers Squibb’s (NYSE: BMY) top selling drugs, pulling sales of $9 billion for full year 2023.

According to BMS, the approved combination for patients with unresectable or metastatic urothelial carcinoma is the first concurrent immunotherapy-chemotherapy combination approved for this population in the USA.

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