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 of Bristol-Myers Squibb's Opdivo (nivolumab) on March 5, 2018, for multiple oncology indications, including melanoma, NSCLC, RCC, and cHL. It details approved dosage regimens (e.g., 480 mg IV Q4W), dose modification guidelines for immune-mediated adverse reactions, and a reduced 30-minute infusion time for several indications. Comprehensive safety profiles from numerous clinical trials (e.g., CHECKMATE-037, -066, -067) are presented, highlighting immune-mediated adverse events like pneumonitis and colitis, their incidence, management, and discontinuation rates. Efficacy data demonstrate significant improvements in overall survival, progression-free survival, and overall response rates for Opdivo as monotherapy and in combination with ipilimumab, often outperforming standard treatments. Bridging analyses confirm comparable efficacy and safety between the 480 mg Q4W and 3 mg/kg Q2W regimens.
Key findings — cited to the page
| Grade 3 or 4 adverse reactions (OPDIVO arm) | 44 % | CHECKMATE-067 · p.33 |
| Vomiting (all grades) | 12 % | CHECKMATE-275 · p.47 |
| gamma-glutamyltransferase increase (grades 3-4) | 3.9 % | 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 higher acute GVHD after allogeneic HSCT after Opdivo | 29 % | · p.26 |
| Grade 3 and 4 adverse reactions | 41 % | CHECKMATE-066 · p.31 |
| Grade 3 and 4 adverse reactions | 42 % | CHECKMATE-037 · p.29 |
| diarrhea (grades 3-4) | 3.4 % | CHECKMATE-066 · p.31 |
| Grade 3 or 4 adverse reactions (OPDIVO-treated patients) | 25 % | CHECKMATE-238 · p.35 |
| Leukopenia (all grades) | 38 % | 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 →