BMS’s sBLA for Opdivo-Based Combination Therapy Receives Acceptance for Priority Review by the US FDA for Urothelial Cancer
Shots:
- The sBLA was accepted by the US FDA for priority review based on the P-III (CheckMate-901) trial evaluating Opdivo + Yervoy or Opdivo + cisplatin-based CT followed by Opdivo monotx. vs SoC CT (gemcitabine + cisplatin) in patients with untreated, unresectable/metastatic urothelial cancer. The US FDA has set a PDUFA date of Apr 05, 2024
- The results from the study depicted that the combination therapy has a statistically significant & clinically meaningful survival benefit along with improvements in 1EPs with an OS of 21.7 vs 18.9mos. & PFS at 7.9 vs 7.6mos.
- Opdivo, a PD-1 immune checkpoint inhibitor, in combination with other therapeutics has depicted improvements in OS under P-III analysis for multiple tumors
Ref: BMS | Image: BMS
Related News:- BMS Receives EMA’s Validation for Opdivo (nivolumab) in Combination with Chemotherapy for the Treatment of Urothelial Carcinoma
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
