BMS Reports EMA’s Validation of MAA for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + CT to Treat Esophageal Squamous Cell Carcinoma

August 17, 2021 Auto Bot BMS, CT, EMA, ipilimumab, MAA, Nivolumab, Opdivo, regulatory, Yervoy 0

Shots:

  • The applications are based on P-III CheckMate -648 trial evaluates Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w up to 24mos.) or Opdivo (nivolumab) + CT vs CT alone in patients with unresectable advanced or metastatic ESCC
  • Results: Both combinations showed OS benefit over CT at the pre-specified interim analysis in patients with tumor cell PD-L1 expression ≥1% & all-randomized population while safety profiles were consistent with the known safety profiles of the individual components
  • The MAA validation confirms that the submissions are complete, and the EMA will now initiate the review procedure. The results were presented at ASCO 2021

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