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, various cancer indications, and dosage regimens, including a new 480 mg every four-week option. It outlines conditions for accelerated approvals and dose modifications for immune-mediated adverse reactions. The report comprehensively covers Opdivo's safety profile, both as a single agent and in combination with ipilimumab, detailing incidence rates, onset times, and management of immune-mediated adverse events across numerous clinical trials (e.g., CHECKMATE-037, -066, -238). Efficacy data, including overall survival and progression-free survival, are presented for various cancers like melanoma, non-small cell lung cancer, and Hodgkin lymphoma, often comparing Opdivo to standard treatments. The 480 mg Q4W regimen is deemed comparable in efficacy and safety to existing doses, with common adverse events including general system disorders, skin conditions, and gastrointestinal issues.
Key findings — cited to the page
| Grade 3 or higher acute GVHD after allogeneic HSCT after OPDIVO | 29 % | · p.26 |
| pneumonitis (all grades) | 6.0 % | CHECKMATE-205 and CHECKMATE-039 · p.44 |
| Grade 3 and 4 adverse reactions | 41 % | CHECKMATE-066 · p.31 |
| Grade 3 or 4 adverse reactions (Opdivo plus ipilimumab arm) | 72 % | CHECKMATE-067 · p.33 |
| fatigue/asthenia (Grade 1-4) | 48 % | CHECKMATE-017 and CHECKMATE-057 · p.38 |
| fatigue/asthenia (Grade 3-4) | 5 % | CHECKMATE-017 and CHECKMATE-057 · p.38 |
| Grade 3 or 4 adverse reactions (Opdivo arm) | 44 % | CHECKMATE-067 · p.33 |
| Grade 3 and 4 adverse reactions | 42 % | CHECKMATE-037 · p.29 |
| gamma-glutamyltransferase increase (Grade 3 and 4) | 3.9 % | CHECKMATE-066 · p.31 |
| diarrhea (Grade 3 and 4) | 3.4 % | CHECKMATE-066 · p.31 |
| Grade 3 or 4 adverse reactions (Opdivo) | 25 % | CHECKMATE-238 · p.35 |
| immune-mediated pneumonitis (all grades) | 4.9 % | CHECKMATE-205 and CHECKMATE-039 · p.44 |
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 →