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Bristol Myers: to request approval for nivolumab

(CercleFinance.com) - The pharma group announces that the phase 3 CheckMate -67T trial of subcutaneous nivolumab (nivolumab and hyaluronidase) has met its co-primary endpoints in advanced or metastatic clear cell renal cell carcinoma.


Subcutaneous nivolumab has non-inferior pharmacokinetics (co-primary endpoints) and objective response rate (key secondary endpoint) compared to intravenous Opdivo (nivolumab).

It now plans to begin talks with health authorities regarding the next steps for submission and approval of subcutaneous nivolumab in several indications.


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