Shots:
- 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| Press Release
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