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Wednesday, January 20, 2021

Priority Review OKd for Bristol Opdivo Adjuvant Therapy for Esophageal, Gastroesophageal Cancer

 U.S. Food and Drug Administration assigned a target action date of May 20, 2021

Application based on Phase 3 CheckMate -577 trial, in which Opdivo doubled median disease-free survival versus placebo in patients with esophageal or gastroesophageal junction cancer following neoadjuvant chemoradiation therapy and surgery

Opdivo demonstrated a manageable safety profile consistent with prior studies

https://www.businesswire.com/news/home/20210120005097/en/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Application-for-Opdivo%C2%AE-nivolumab-as-Adjuvant-Therapy-for-Patients-with-Resected-Esophageal-or-Gastroesophageal-Junction-Cancer

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