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BMS’ Opdivo Qvantig SC Injection Secures the US FDA’s Approval for Solid Tumor Opdivo Indications

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BMS’ Opdivo Qvantig SC Injection Secures the US FDA’s Approval for Solid Tumor Opdivo Indications

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  • The US FDA has approved Opdivo Qvantig (nivolumab & hyaluronidase-nvhy) SC injection for previously approved solid tumor Opdivo indications, incl. as monotx., maintenance therapy after Opdivo-Yervoy combination & with CT or cabozantinib
  • Approval was based on P-III (CheckMate-67T) study assessing Opdivo Qvantig (nivolumab: 1,200mg & hyaluronidase: 20,000 units, SC, Q4W; n=248) vs Opdivo (3mg/kg, IV, Q2W; n=247) in adults (N=495) with advanced or metastatic ccRCC treated previously with systemic therapy
  • Study depicted noninferiority in co-1EPs of Cavgd28 (GMR: 2.10) and Cminss (GMR: 1.77). The ORR was 24% vs 18%, showing comparable efficacy

Ref: BMS | Image: BMS

Related News:- BMS Reports the EC’s Approval of Opdivo (Nivolumab) Plus Yervoy (Ipilimumab) as a 1L Treatment of MSI-H/dMMR Metastatic Colorectal Cancer (mCRC)

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Disha Nankani

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.

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