BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2018)
Bristol-Myers Squibb Company · 2018 · FDA Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA approval of Bristol-Myers Squibb's Opdivo (nivolumab) on March 5, 2018, for multiple oncology indications, including melanoma, NSCLC, RCC, cHL, SCCHN, urothelial carcinoma, MSI-H colorectal cancer, and hepatocellular carcinoma. It details the drug's safety profile, highlighting immune-mediated adverse reactions, their incidence, management, and comparison to other treatments across numerous clinical trials (e.g., CHECKMATE-037, -066, -067, -238, -017, -057, -025, -205, -039). Efficacy data, including improved recurrence-free survival and overall survival, are presented for various cancer types. The report also covers the approval of a new 480 mg every four-week dosage regimen and 30-minute infusion duration, based on pharmacokinetic modeling and comparable safety/efficacy to existing regimens, with no new safety concerns identified.
Key findings — cited to the page
| rash (Grade 3-4) | 0.4 % | CHECKMATE-037 · p.29 |
| cough (all grades) | 17 % | CHECKMATE-037 · p.29 |
| fatigue (Grade 3-4, OPDIVO arm) | 1.9 % | CHECKMATE-067 · p.33 |
| rash (all grades) | 21 % | CHECKMATE-037 · p.29 |
| pruritus (all grades) | 19 % | CHECKMATE-037 · p.29 |
| pruritus (Grade 3-4) | 0 % | CHECKMATE-037 · p.29 |
| increased ALT (all grades) | 25 % | CHECKMATE-066 · p.32 |
| Grade 3 or higher acute GVHD after allogeneic HSCT after OPDIVO | 29% | · p.26 |
| Anemia (all grades) | 40 % | CHECKMATE-275 · p.48 |
| Grade 3 and 4 adverse reactions | 42 % | CHECKMATE-037 · p.29 |
| vitiligo (Grade 3-4) | 0 % | CHECKMATE-066 · p.31 |
| cough (Grade 3-4) | 0 % | CHECKMATE-037 · p.29 |
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 →