India, April 26 -- Bristol Myers Squibb (BMY) announced the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended approval of Opdivo in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The positive CHMP opinion is based on results from a sub-study of the CheckMate -901 trial. The European Commission will review the CHMP recommendation. The final EC decision is anticipated in June 2024.
On March 7, 2024 the FDA approved the use of Opdivo in combination with cisplatin and gemcitabine as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma, following a Priori...