BRISTOL MYERS SQUIBB — Opdivo FDA Review (NDA/BLA 125554, 2018)
Bristol-Myers Squibb Company · 2018 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package for Bristol-Myers Squibb's Opdivo (nivolumab), dated March 5, 2018, details its approved indications across various cancers including melanoma, NSCLC, RCC, Hodgkin lymphoma, SCCHN, urothelial carcinoma, MSI-H/dMMR colorectal cancer, and hepatocellular carcinoma. It introduces new 480 mg every 4 weeks dosage regimens and reduced infusion times, supported by pharmacokinetic modeling and clinical safety data demonstrating comparable efficacy and safety to existing regimens. The report extensively covers Opdivo's safety profile, both as monotherapy and in combination with ipilimumab, highlighting immune-mediated adverse reactions, their incidence, management, and Grade 3/4 events across numerous clinical trials. Efficacy data, including overall survival, progression-free survival, and overall response rates, are presented for various indications. The safety profile of the 480 mg Q4W regimen is consistent with current labeling.
Key findings — cited to the page
| rash (Grade 3-4) | 0.4 % | CHECKMATE-037 · p.29 |
| pruritus (all grades) | 19 % | CHECKMATE-037 · p.29 |
| rash (Grade 3-4) | 1.1 % | CHECKMATE-238 · p.36 |
| rash (all grades) | 21 % | CHECKMATE-037 · p.29 |
| Grade 3 and 4 adverse reactions | 42 % | CHECKMATE-037 · p.29 |
| vitiligo (Grade 3-4) | 0 % | CHECKMATE-066 · p.31 |
| increased ALT (Grade 3-4) | 1.6 % | CHECKMATE-037 · p.30 |
| hyperkalemia (all grades) | 15 % | CHECKMATE-037 · p.30 |
| pruritus (Grade 3-4) | 0 % | CHECKMATE-238 · p.36 |
| pruritus (all grades) | 28 % | CHECKMATE-238 · p.36 |
| Grade 3 or higher acute GVHD incidence after allogeneic HSCT after OPDIVO | 5/17 (29%) | · p.26 |
| pruritus (Grade 3-4) | 0 % | 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 →