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FDA accepts sBLA for Opdivo to treat patients with resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting. - BMS

Read time: 1 mins
Published:22nd Jan 2021
Bristol Myers Squibb announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy (CRT). The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 20, 2021. The filing was based on results from the Phase III CheckMate -577 trial, which is the first trial to show positive results in the adjuvant setting in this group of patients. The study met its primary endpoint of disease-free survival (DFS) in patients with esophageal or GEJ cancer, following neoadjuvant CRT and tumor resection. Results from the CheckMate -577 trial place esophageal and GEJ cancer among four tumor types – in addition to melanoma, bladder and non-small cell lung cancer – for which Opdivo has shown a benefit in the early disease setting. The safety profile of Opdivo as adjuvant therapy in the CheckMate -577 trial was consistent with that reported in previous studies.
Condition: Oesophageal Cancer
Type: drug

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