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BMS' Opdivo (nivolumab) Receives the US FDA's Approval for Advanced Esophageal Squamous Cell Carcinoma

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BMS' Opdivo (nivolumab) Receives the US FDA's Approval for Advanced Esophageal Squamous Cell Carcinoma

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  • The US FDA’s approval is based on P-III ATTRACTION-3 study assessing Opdivo (240mg by IV infusion over 30min- q2w) vs taxane CT (docetaxel/paclitaxel) in patients with unresectable advanced- recurrent or ESCC- refractory/ intolerant to at least one prior fluoropyrimidine & platinum-based CT
  • Opdivo is the first approved immunotherapy in this setting regardless of tumor PD-L1 expression level. Efficacy results: OS (10.9 vs 8.4mos.); ORR (19.3% vs 21.5%); median PFS (1.7 vs 3.4mos.)
  • Opdivo is a PD-1 immune check inhibitor harnessing the body’s own immune system to restore anti-tumor immune response

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Ref: Business wire | Image: BMS

 


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