Posted by Michael Wonder on 27 Apr 2024
CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
26 April 2024 - Recommendation based on results from CheckMate-901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit versus standard of care chemotherapy alone in cisplatin-eligible adults with unresectable or metastatic urothelial carcinoma.
Bristol Myers Squibb today announced that the CHMP of the EMA has recommended approval of Opdivo (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
