Posted by Michael Wonder on 27 Sep 2021
U.S. Food and Drug Administration accepts Bristol Myers Squibb’s applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + chemotherapy for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
27 September 2021 - Applications based on Phase 3 CheckMate-648 trial, in which both Opdivo-based combinations demonstrated a significant overall survival benefit over chemotherapy alone.
Bristol Myers Squibb today announced that the U.S. FDA has accepted the supplemental biologics license 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, based on results from the CheckMate -648 trial.
The FDA assigned a Prescription Drug User Fee Act goal date of 28 May 2022.
