Bristol Myers' Two Opdivo Based Regimes Under FDA Review For Esophageal Cancer
- The FDA has accepted for review Bristol Myers Squibb & Co Inc's (NYSE: BMY) supplemental marketing applications seeking approval for two Opdivo (nivolumab) based combo regimes for esophageal squamous cell carcinoma.
- The application cover Opdivo / Yervoy (ipilimumab) and Opdivo / fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for adult patients with unresectable advanced, recurrent or metastatic ESCC.
- The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 28, 2022.
- In CheckMate -648, both Opdivo-based treatment combinations demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: BMY stock is up 0.75% at $60.68 during the market session on the last check Monday.
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Posted-In: Briefs Esophageal CancerBiotech News Health Care FDA General
