BMS’ Opdivo (nivolumab) in Combination with Cisplatin and Gemcitabine Receives the US FDA’s Approval for the Treatment of Urothelial Carcinoma (UC)
Shots:
- The approval was based on the results from the P-III (CheckMate-901) trial evaluating Opdivo + cisplatin + gemcitabine followed by Opdivo monox. vs cisplatin-gemcitabine alone in patients (n=304 vs 304) with previously untreated unresectable or metastatic UC. The 1EPs include OS & PFS
- At a median follow-up of 33mos., the study depicted a 22% reduction in risk of death & 28% reduction in risk of disease progression with the combination therapy, a mOS of 21.7mos. vs 18.9mos. & mPFS of 7.9mos. vs 7.6mos.
- Under exploratory analysis, the study showed an ORR of 57.6% vs 43.1% whereas the CR & PR rates were 22% vs 12% & 36% vs 31%. Additionally, BMS’ sBLA was approved following the Priority Review status granted by the US FDA
Ref: BMS | Image: BMS
Related News:- BMS Reports 4-Year Follow-Up Data for Opdivo with Cabometyx in P-III Trial to Treat Advanced Renal Cell Carcinoma (RCC)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
