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U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy | Antibodies


In CheckMate -577, Opdivo
1
Approval expands the role of Opdivo
in earlier stages of disease, with two indications in the adjuvant setting across three types of cancer
1
PRINCETON, NJ, USA I May 20, 2021 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved
Opdivo
® (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).
1 The approval is based on results from the Phase 3 CheckMate -577 trial that evaluated
Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection. ....

Baylor University , United States , South Korea , Ronanj Kelly , Adam Lenkowsky , I Bristol Myers Squibb , Neoadjuvant Downstaging , Neoadjuvant Chemoradiotherapy , Gastroenterol Hepatol , Bristol Myers Squibb , Ww Caruth Jr , Association With Baseline Variables , Bristol Myers Squibb Company , Time Oncology Review Pilot Program , Virtual Congress , Drug Administration Approves Opdivo , American Cancer Society , National Comprehensive Cancer Network , University Of Texas Md Anderson Cancer Center , Drug Administration , Us Food Drug Administration , Ono Pharmaceutical Co , European Society For Medical Oncology , Immunology At Baylor University Medical Center , Adjuvant Treatment , Completely Resected Esophageal ,