BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)
Bristol-Myers Squibb Company · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package for Bristol-Myers Squibb's Opdivo (nivolumab) details its March 5, 2018 approval and numerous indications across various cancers, including melanoma, NSCLC, RCC, and cHL. It outlines new dosage regimens (e.g., 480 mg Q4W) and reduced infusion times. The report comprehensively covers Opdivo's safety profile, both as monotherapy and in combination with ipilimumab, highlighting immune-mediated adverse reactions, their incidence, onset, and management strategies. Efficacy data, including overall survival, progression-free survival, and overall response rates, are presented from multiple clinical trials (e.g., CHECKMATE-037, -066, -067, -238, -017, -057, -025, -205, -039, -141, -275, -142, -040), often comparing Opdivo to standard treatments. Regulatory history and pharmacokinetic bridging analyses for new dosing regimens are also included.
Key findings — cited to the page
| rash (Grade 3-4) | 0.4 % | CHECKMATE-037 · p.29 |
| upper respiratory tract infection (all grades) | 11 % | CHECKMATE-037 · p.29 |
| diarrhea (all grades, Opdivo) | 37 % | CHECKMATE-238 · p.36 |
| rash (all grades) | 21 % | CHECKMATE-037 · p.29 |
| cough (all grades) | 17 % | CHECKMATE-037 · p.29 |
| increased alkaline phosphatase (all grades) | 21 % | CHECKMATE-066 · p.32 |
| increased AST (Grade 3-4) | 3.6 % | CHECKMATE-066 · p.32 |
| hyponatremia (Grade 3-4, Opdivo plus Ipilimumab arm) | 9 % | CHECKMATE-067 · p.34 |
| pruritus (Grade 3-4) | 0.5 % | CHECKMATE-066 · p.31 |
| Grade 3 and 4 adverse reactions | 42 % | CHECKMATE-037 · p.29 |
| pruritus (all grades) | 19 % | CHECKMATE-037 · p.29 |
| peripheral edema (all grades) | 10 % | 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 →