Bristol-Myers Squibb Company — Opdivo FDA Review (NDA/BLA 125554, 2023)
Bristol-Myers Squibb Company · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
Bristol-Myers Squibb's Opdivo (nivolumab), alone or with Yervoy (ipilimumab), received FDA approval on May 15, 2020, for various cancers, including first-line metastatic non-small cell lung cancer (NSCLC) with PD-L1 (≥1%). Clinical trials (e.g., CHECKMATE series) demonstrated significant improvements in overall survival, progression-free survival, and overall response rates across multiple indications like melanoma, renal cell carcinoma, and classical Hodgkin lymphoma. The report details comprehensive safety profiles, including incidence, onset, and management of immune-mediated adverse reactions (e.g., pneumonitis, colitis, nephritis) and infusion-related reactions. Dose modifications for these adverse events are provided. Regulatory interactions, clinical pharmacology, immunogenicity, and financial disclosures related to the trials are also covered.
Key findings — cited to the page
| Cough incidence (all grades) in CHECKMATE-037 (OPDIVO) | 17 % | CHECKMATE-037 · p.31 |
| Pruritus incidence (all grades) in CHECKMATE-037 (OPDIVO) | 19 % | CHECKMATE-037 · p.31 |
| Grade 3 immune-mediated pneumonitis incidence in NSCLC | 3.5% | OPDIVO 3 mg/kg every 2 weeks with ipilimumab 1 mg/kg every 6 weeks · p.19 |
| Pruritus incidence (all grades) in CHECKMATE-066 (OPDIVO) | 23 % | CHECKMATE-066 · p.33 |
| Rash incidence (all grades) in CHECKMATE-037 (OPDIVO) | 21 % | CHECKMATE-037 · p.31 |
| Rash incidence (Grade 3-4) in CHECKMATE-037 (OPDIVO) | 0.4 % | CHECKMATE-037 · p.31 |
| Pruritus incidence (Grade 3-4) in CHECKMATE-066 (OPDIVO) | 0.5 % | CHECKMATE-066 · p.33 |
| Grade 4 immune-mediated pneumonitis incidence in NSCLC | 0.5% | OPDIVO 3 mg/kg every 2 weeks with ipilimumab 1 mg/kg every 6 weeks · p.19 |
| Grade 2 immune-mediated pneumonitis incidence in NSCLC | 4.0% | OPDIVO 3 mg/kg every 2 weeks with ipilimumab 1 mg/kg every 6 weeks · p.19 |
| Vitiligo incidence (all grades) in CHECKMATE-066 (OPDIVO) | 11 % | CHECKMATE-066 · p.33 |
| Grade 3 and 4 adverse reactions incidence in CHECKMATE-037 (OPDIVO) | 42 % | CHECKMATE-037 · p.31 |
| Upper respiratory tract infection incidence (all grades) in CHECKMATE-037 (OPDIVO) | 11 % | CHECKMATE-037 · p.31 |
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 →