Posted by Michael Wonder on 17 Aug 2021
EMA validates Bristol Myers Squibb’s applications for Opdivo (nivolumab) and Yervoy (ipilimumab) and Opdivo and chemotherapy as first-line treatments for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
17 August 2021 - Applications based on positive results from the Phase 3 CheckMate-648 trial, in which both Opdivo-based combinations demonstrated a significant survival benefit over chemotherapy alone.
Bristol Myers Squibb today announced that the EMA has validated its Type II variation marketing authorisation applications for both Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma.
