BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2021)
Bristol-Myers Squibb Company · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Bristol-Myers Squibb's Opdivo (nivolumab) for unresectable or metastatic melanoma in patients progressing after ipilimumab and, if BRAF V600 positive, a BRAF inhibitor. This accelerated approval was based on tumor response rate and durability. The report details Opdivo's mechanism as an anti-PD-1 antibody, its pharmacokinetics, and specific population considerations. Clinical trials, specifically Trial 1, demonstrated an objective response rate of 32%. The document also outlines dosage, administration, and significant warnings regarding immune-mediated adverse reactions.
Key findings — cited to the page
| Grade 1 or 2 hyperthyroidism | 3 % | OPDIVO (nivolumab) · p.11 |
| Rash (all grades) | 21 % | OPDIVO (nivolumab) · p.13 |
| Grade 2 or 3 immune-mediated nephritis or renal dysfunction | 0.7 % | OPDIVO (nivolumab) · p.10 |
| Grade 1 or 2 hypothyroidism | 0 % | Chemotherapy · p.11 |
| Grade 1 or 2 hyperthyroidism | 1 % | Chemotherapy · p.11 |
| Grade 3 and 4 adverse reactions | 42 % | OPDIVO (nivolumab) · p.13 |
| Diarrhea or colitis (all grades) | 18 % | Chemotherapy · p.9 |
| Pneumonitis (all grades) | 3.4 % | OPDIVO (nivolumab) · p.9 |
| Pneumonitis (all grades) | 0 % | Chemotherapy · p.9 |
| Grade 1 or 2 hypothyroidism | 8 % | OPDIVO (nivolumab) · p.11 |
| Diarrhea or colitis (all grades) | 21 % | OPDIVO (nivolumab) · p.9 |
| Rash (Grade 3-4) | 0.4 % | OPDIVO (nivolumab) · p.13 |
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 →