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# FDA Approves BMS’ Opdivo for Some Cancer Patients
- URL: https://www.fdaweb.com/fda-approves-bms-opdivo-for-some-cancer-patients/
- Published: 2020-06-11T12:00:00.000Z
- Updated: 2026-09-14T16:17:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146978

FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. An agency [notice](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-nivolumab-esophageal-squamous-cell-carcinoma?ref=fdaweb.com) says the drug’s efficacy was investigated in the ATTRACTION-3 trial involving 419 patients. The trial demonstrated a statistically significant improvement in overall survival, the major efficacy outcome measure, FDA says.

The most common adverse reactions were rash, decreased appetite, diarrhea, constipation, musculoskeletal pain, upper respiratory tract infection, cough, pyrexia, pneumonia, anemia, fatigue, pruritus, nausea, and hypothyroidism.

Opdivo had been granted priority review and orphan drug designation.