BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)
Bristol-Myers Squibb Company · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
Bristol-Myers Squibb's Opdivo (nivolumab) received FDA approval for various cancer types, including melanoma, NSCLC, RCC, cHL, SCCHN, urothelial carcinoma, MSI-H/dMMR mCRC, and hepatocellular carcinoma (HCC). Several indications, particularly HCC, received accelerated approval based on tumor response rates and durability, contingent on confirmatory trials. Efficacy was demonstrated across multiple CHECKMATE trials, showing improved overall survival and response rates compared to standard treatments. The safety profile, detailed for single-agent and combination use with ipilimumab, highlights immune-mediated adverse reactions like colitis, hepatitis, and endocrinopathies, with management strategies outlined. While generally consistent, HCC patients showed a higher incidence of transaminase and bilirubin elevations. Pharmacokinetic analyses support a 240 mg Q2W flat dose.
Key findings — cited to the page
| pruritus incidence (all grades) with OPDIVO in CHECKMATE-037 | 19 % | CHECKMATE-037 · p.28 |
| increased AST (all grades) with OPDIVO in CHECKMATE-037 | 28 % | CHECKMATE-037 · p.29 |
| Grade 3 or higher acute GVHD after allogeneic HSCT after OPDIVO | 29 % | · p.25 |
| rash incidence (all grades) with OPDIVO in CHECKMATE-037 | 21 % | CHECKMATE-037 · p.28 |
| upper respiratory tract infection incidence (all grades) with OPDIVO in CHECKMATE-037 | 11 % | CHECKMATE-037 · p.28 |
| peripheral edema incidence (all grades) with OPDIVO in CHECKMATE-037 | 10 % | CHECKMATE-037 · p.28 |
| Treatment-emergent Grade 3 or 4 AST | 18% | · p.109 |
| rash incidence (grades 3-4) with OPDIVO in CHECKMATE-037 | 0.4 % | CHECKMATE-037 · p.28 |
| Grade 3 and 4 adverse reactions with OPDIVO in CHECKMATE-037 | 42 % | CHECKMATE-037 · p.27 |
| Treatment-emergent Grade 3 or 4 ALT | 11% | · p.109 |
| cough incidence (all grades) with OPDIVO in CHECKMATE-037 | 17 % | CHECKMATE-037 · p.28 |
| increased AST (grades 3-4) with OPDIVO in CHECKMATE-037 | 2.4 % | 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 →