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 approval, indications across various cancer types (melanoma, NSCLC, RCC, Hodgkin lymphoma, HNSCC, urothelial, MSI-H/dMMR colorectal, HCC), and dosage regimens, including a new 480 mg Q4W dose and 30-minute infusion. The report outlines the regulatory process, including accelerated approvals based on efficacy metrics like overall survival, progression-free survival, and overall response rates from numerous clinical trials (e.g., CHECKMATE-037, -066, -067, -238, -017, -057, -025, -205, -039, -141, -275, -142, -040). It comprehensively covers the safety profile, both as a single agent and in combination with ipilimumab, focusing on immune-mediated adverse reactions, their incidence, onset, and management strategies, and compares Opdivo to other treatments. Efficacy and safety bridging analyses confirm the comparability of the 480 mg Q4W regimen to previous dosing.
Key findings — cited to the page
| Abdominal pain (all grades) | 13 % | CHECKMATE-275 · p.47 |
| Leukopenia (grades 3-4) | 4.5 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
| Constipation (grades 3-4) | 0.4 % | CHECKMATE-275 · p.47 |
| Grade 3 and 4 adverse reactions | 42 % | CHECKMATE-037 · p.29 |
| Diarrhea (grades 3-4) | 2.6 % | CHECKMATE-275 · p.47 |
| Constipation (all grades) | 16 % | CHECKMATE-275 · p.47 |
| Leukopenia (all grades) | 38 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
| Rash (grades 3-4) | 1.5 % | CHECKMATE-275 · p.47 |
| Grade 3 or higher acute GVHD incidence after allogeneic HSCT | 29 % | · p.26 |
| Diarrhea (all grades) | 17 % | CHECKMATE-275 · p.47 |
| Neutropenia (all grades) | 37 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
| Vomiting (all grades) | 12 % | CHECKMATE-275 · p.47 |
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 →