nivolumab (Opdivo) plus cisplatin and gemcitabine: FDA status

Approved Approved Mar 6, 2024. Indication: First line treatment of metastatic urothelial carcinoma. Company: Bristol Myers Squibb.

Regulatory history

• Mar 6, 2024: Accelerated approval. FDA granted accelerated approval to nivolumab plus cisplatin and gemcitabine as first line treatment for unresectable or metastatic urothelial carcinoma based on CheckMate 901. cancernetwork.com

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