BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2021)
Bristol-Myers Squibb Company · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Opdivo (nivolumab) for unresectable or metastatic melanoma in patients progressing after ipilimumab (and BRAF inhibitor if BRAF V600 positive). This accelerated approval, based on tumor response rate and durability, requires confirmatory trials. The report details Opdivo's mechanism of action, pharmacokinetics, dosage, administration, and significant immune-mediated adverse reactions. Clinical studies showed an objective response rate of 32% in a single-arm trial.
Key findings — cited to the page
| Increased total bilirubin rate (all grades) | 9% | OPDIVO (nivolumab) · p.10 |
| Immune-mediated hepatitis rate (all grades) | 1.1% | OPDIVO (nivolumab) · p.10 |
| Immune-mediated colitis rate (all grades) | 2.2% | OPDIVO (nivolumab) · p.9 |
| Increased ALT rate (all grades) | 16% | OPDIVO (nivolumab) · p.10 |
| Immune-mediated pneumonitis rate (all grades) | 2.2% | OPDIVO (nivolumab) · p.9 |
| Diarrhea or colitis rate (all grades) | 21% | OPDIVO (nivolumab) · p.9 |
| Pneumonitis rate (all grades) | 3.4% | OPDIVO (nivolumab) · p.9 |
| Increased alkaline phosphatase incidence (chemotherapy arm, all grades) | 13 % | OPDIVO (nivolumab) · p.15 |
| Increased AST rate (all grades) | 28% | OPDIVO (nivolumab) · p.10 |
| Increased alkaline phosphatase rate (all grades) | 22% | OPDIVO (nivolumab) · p.10 |
| Most common adverse reaction (all grades) | rash | OPDIVO (nivolumab) · p.6 |
| Elevated creatinine rate (all grades) | 13% | OPDIVO (nivolumab) · p.10 |
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 →