BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2023)
Bristol-Myers Squibb Company · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Bristol-Myers Squibb's Opdivo (nivolumab), approved November 10, 2016, for multiple indications including melanoma, NSCLC, renal cell carcinoma, classical Hodgkin lymphoma, and SCCHN. The report covers its mechanism, pharmacokinetics, and extensive efficacy data from various trials, often comparing it to standard treatments. A significant focus is on Opdivo's safety profile, detailing immune-mediated adverse reactions like colitis, hepatitis, and endocrinopathies, their incidence, onset, and management. It also addresses immunogenicity, supply, storage, and patient counseling. Notably, Study CA209141 demonstrated significant overall survival improvement for nivolumab in platinum-refractory SCCHN, despite serious adverse events in 49% of patients. Regulatory activities, post-market safety concerns, and specific population data are also included.
Key findings — cited to the page
| Grade 3 or higher acute GVHD | 29 % | · p.24 |
| Grade 3 and 4 adverse reactions | 42 % | Trial 1 · p.26 |
| Grade 3 and 4 adverse reactions | 41 % | Trial 4 · p.28 |
| Patients permanently discontinued OPDIVO due to Grade 2 pneumonitis | 1 | Trials 7 and 8 · p.39 |
| Grade 3 peripheral neuropathy | 1 | Trials 7 and 8 · p.39 |
| Grade 3 peripheral neuropathy | 0.4 % | Trials 7 and 8 · p.39 |
| Grade 3 immune-mediated pneumonitis | 1 | Trials 7 and 8 · p.39 |
| Grade 2 immune-mediated pneumonitis | 8 | Trials 7 and 8 · p.39 |
| Grade 3 or 4 adverse reactions in OPDIVO plus ipilimumab arm | 72 % | Trial 6 · p.30 |
| Grade 3 or 4 adverse reactions in OPDIVO arm | 44 % | Trial 6 · p.31 |
| Pyrexia (Grades 3-4) | 0.6 % | Trial 6 · p.31 |
| Increased AST (All Grades) | 24 % | Trial 4 · p.30 |
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 →