BMS Receives EMA’s Validation for Opdivo (nivolumab) in Combination with Chemotherapy for the Treatment of Urothelial Carcinoma
Shots:
- The EMA accepted BMS' type II variation application for Opdivo + cisplatin-based CT as 1L treatment of adult patients with unresectable/metastatic urothelial carcinoma based on the results from the P-III (CheckMate-901) study
- The P-III (CheckMate-901) clinical trial evaluates the safety & efficacy of Opdivo (360mg, Q3W) + cisplatin-based CT followed by Opdivo monotx. (480mg, Q4W) vs SoC CT in patients (n=608) with urothelial carcinoma. The company is currently evaluating Opdivo + Yervoy vs SoC CT for the same indication
- The P-III efficacy results, presented at ESMO’23, showed improved OS and PFS as evaluated by BICR. Safety profiles were tolerable and consistent
Ref: BMS | Image: BMS
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
