FDA approves Opdivo-based combinations for esophageal squamous cell carcinoma

The FDA approved nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as first-line treatments for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma.The agency based the approvals of the nivolumab (Opdivo, Bristol Myers Squibb) regimens on results of the randomized phase 3 CheckMate -648 trial, which investigated the anti-PD-1 antibody in combination with fluorouracil and cisplatin chemotherapy (n = 321) and in combination with ipilimumab (Yervoy, Bristol Myers Squibb), an anti-CTLA-4 antibody (n = 325) comparedRead More

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