Bristol-Myers Squibb Company — Opdivo FDA Review (NDA/BLA 125554, 2023)
Bristol-Myers Squibb Company · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Bristol-Myers Squibb's Opdivo (nivolumab) on June 10, 2020, for numerous cancer indications, including melanoma, lung, renal cell, and esophageal squamous cell carcinoma (ESCC), as a single agent or in combination with ipilimumab. The approval package details recommended dosages, administration schedules, and dose modifications for immune-mediated adverse reactions. Efficacy data from multiple CHECKMATE and ATTRACTION trials demonstrate Opdivo's benefits in overall survival, progression-free survival, and overall response rates across various cancer types. While generally well-tolerated, the safety profile highlights immune-mediated adverse events like nephritis, rash, and pneumonitis. For ESCC, Opdivo showed superior overall survival compared to chemotherapy, but esophageal fistula emerged as a new safety signal, and pneumonitis incidence was higher. The regulatory review also addressed drug product comparability and assay validation.
Key findings — cited to the page
| Incidence of Grade 3 and 4 neutropenia with docetaxel | 88 % | · p.141 |
| Incidence of Grade 3 fatigue with docetaxel | 12 % | · p.141 |
| Incidence of Grade 3 or 4 rash with nivolumab | 2 % | Study ONO-4538-24 · p.127 |
| Incidence of Grade 3 and 4 leukopenia with docetaxel | 73 % | · p.141 |
| Incidence of Grade 3 and 4 anemia with docetaxel | 12 % | · p.141 |
| Incidence of Grade 3 anorexia with docetaxel | 18 % | · p.141 |
| Incidence of Grade 3 or 4 anemia with nivolumab | 8 % | Study ONO-4538-24 · p.127 |
| Incidence of Grade 3 or 4 pneumonia with nivolumab | 5 % | Study ONO-4538-24 · p.127 |
| Incidence of Grade 3 or 4 decreased appetite with nivolumab | 2 % | Study ONO-4538-24 · p.127 |
| Incidence of Grade 3 or 4 diarrhea with nivolumab | 2 % | Study ONO-4538-24 · p.127 |
| Incidence of Grade 3 and 4 febrile neutropenia with docetaxel | 18 % | · p.141 |
| Incidence of Grade 3 diarrhea with docetaxel | 6 % | · p.141 |
Source: Bristol-Myers Squibb Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →