BMS Reports the US FDA’s Updated Action Date for Subcutaneous Opdivo (Nivolumab and Hyaluronidase)
Shots:
- The US FDA has updated the target action date from Feb 28, 2025 to Dec 29, 2024 for the BLA of SC Opdivo co-formulated with Halozyme’s recombinant human hyaluronidase (rHuPH20) for all the approved solid tumor indications as monotx. and in combinations
- The BLA was based on the P-III (CheckMate -67T) trial assessing Opdivo (SC) co-formulated with rHuPH20 vs Opdivo (IV) for treating advanced or metastatic clear cell renal cell carcinoma (ccRCC) patients previously treated with systemic therapy
- The study demonstrated noninferiority of Cavgd28 & Cminss along with ORR using Opdivo (SC) vs Opdivo (IV). The safety profile of SC formulation was comparable with the IV formulation; data was highlighted at ASCO GU 2024
Ref: BMS | Image: BMS
Related News:- BMS Reports the Updated Data from P-III (CheckMate -73L) Study of Opdivo for Non-Small Cell Lung Cancer
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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.
