BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2020)
Bristol-Myers Squibb Company · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
This report summarizes the FDA approval package for Bristol-Myers Squibb's Opdivo (nivolumab), detailing its approval date, multiple cancer indications (melanoma, NSCLC, RCC, cHL, HNSCC, urothelial, MSI-H/dMMR colorectal, hepatocellular carcinoma), and updated dosage regimens (240 mg Q2W and 480 mg Q4W). It highlights indications receiving accelerated approval based on surrogate endpoints. The report extensively covers Opdivo's safety profile, both as monotherapy and in combination with ipilimumab, focusing on immune-mediated adverse reactions, their incidence, onset, and management. Efficacy data from numerous CHECKMATE trials demonstrate significant improvements in overall survival, progression-free survival, and response rates across various cancer types. The 480 mg Q4W regimen is deemed comparable in efficacy and safety to the established 3 mg/kg Q2W regimen based on pharmacokinetic modeling and clinical data.
Key findings — cited to the page
| Neutropenia (all grades) | 37 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
| Thrombocytopenia (all grades) | 37 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
| Grade 3 or 4 adverse reactions | 44 % | CHECKMATE-067 · p.33 |
| Leukopenia (grades 3-4) | 4.5 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
| Grade 3 and 4 adverse reactions | 42 % | CHECKMATE-037 · p.29 |
| Neutropenia (grades 3-4) | 5 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
| Grade 3 and 4 adverse reactions | 41 % | CHECKMATE-066 · p.31 |
| Grade 3 or 4 adverse reactions | 72 % | CHECKMATE-067 · p.33 |
| Grade 3 or 4 adverse reactions | 25 % | CHECKMATE-238 · p.35 |
| Leukopenia (all grades) | 38 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
| Grade 3 or higher acute GVHD incidence after allogeneic HSCT | 29 % | · p.26 |
| Thrombocytopenia (grades 3-4) | 3.0 % | CHECKMATE-205 and CHECKMATE-039 · p.45 |
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 →