Bristol Myers Squibb announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Opdivo (nivolumab) in combination with cisplatin and gemcitabine as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.

The European Commission (EC), which has the power to approve medicines for the European Union (EU), will now re-examine the CHMP recommendation. The EC's final decision is expected in June 2024.

With this positive CHMP opinion, 'we are one step closer to providing eligible patients with unresectable or metastatic urothelial carcinoma in the European Union with a new first-line treatment option', commented Dana Walker, Vice President and Global Program Leader, Genitourinary Cancers, Bristol Myers Squibb.


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