The US FDA has accepted 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 with the decision anticipated on Feb 28, 2025
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
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