BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2018)
Bristol-Myers Squibb Company · 2018 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Bristol-Myers Squibb's Opdivo (nivolumab) for various cancer indications, including metastatic melanoma, NSCLC, RCC, and cHL, with specific dosage regimens. Accelerated approvals were granted for some indications based on surrogate endpoints, pending confirmatory trials. Opdivo's safety profile, as monotherapy and in combination with ipilimumab, highlights immune-mediated adverse reactions like pneumonitis, colitis, and endocrinopathies, with detailed incidence, onset, and management strategies. Clinical trials (e.g., CHECKMATE-037, -066, -067) consistently reported adverse event rates, serious adverse reactions, and discontinuation rates across different cancer types, often comparing Opdivo to chemotherapy or other standard treatments. Efficacy data, including overall survival, progression-free survival, and overall response rates, were presented for numerous trials (e.g., CHECKMATE-238, -017, -057, -025, -205/039, -141, -275, -142, -040). The FDA also approved a new 480 mg every four-week dosage regimen, supported by pharmacokinetic modeling and clinical safety data demonstrating comparable efficacy and safety to the existing 3 mg/kg Q2W regimen. Immunogenicity data and laboratory abnormalities were also detailed.
Key findings — cited to the page
| infusion-related reaction (all grades) | 14 % | CHECKMATE-205 and CHECKMATE-039 · p.43 |
| Diarrhea (grades 3-4) | 2.6 % | CHECKMATE-275 · p.47 |
| arthralgia (all grades) | 16 % | CHECKMATE-205 and CHECKMATE-039 · p.43 |
| neuropathy peripheral (all grades) | 12 % | CHECKMATE-205 and CHECKMATE-039 · p.43 |
| musculoskeletal pain (all grades) | 26 % | CHECKMATE-205 and CHECKMATE-039 · p.43 |
| increased ALT (Grade 3-4) | 1.6 % | CHECKMATE-037 · p.30 |
| Hyperglycemia (grades 3-4) | 2.4 % | CHECKMATE-275 · p.48 |
| musculoskeletal pain (Grade 3-4) | 1.1 % | CHECKMATE-205 and CHECKMATE-039 · p.43 |
| hypothyroidism/thyroiditis (all grades) | 12 % | CHECKMATE-205 and CHECKMATE-039 · p.43 |
| headache (all grades) | 17 % | CHECKMATE-205 and CHECKMATE-039 · p.43 |
| Constipation (all grades) | 16 % | CHECKMATE-275 · p.47 |
| pruritus (all grades) | 19 % | 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 →