Posted by Michael Wonder on 28 May 2022
U.S. Food and Drug Administration approves two Opdivo (nivolumab) based regimens as first-line treatments for unresectable advanced or metastatic oesophageal squamous cell carcinoma
27 May 2022 - Opdivo in combination with chemotherapy and Opdivo plus Yervoy (ipilimumab) approved based on a Phase 3 trial showing improved overall survival versus chemotherapy alone.
Bristol Myers Squibb today announced that the U.S. FDA has approved both Opdivo (nivolumab) (injection for intravenous use) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo plus Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable advanced or metastatic oesophageal squamous cell carcinoma regardless of PD-L1 status.
The approvals are based on the Phase 3 CheckMate-648 trial, which evaluated Opdivo in combination with chemotherapy (n=321) and Opdivo plus Yervoy (n=325) each compared to chemotherapy alone (n=324), and was the largest Phase 3 trial of an immunotherapy in first-line oesophageal squamous cell carcinoma.
