BRISTOL MYERS SQUIBB — Yervoy FDA Review (NDA/BLA 125377, 2021)
Bristol-Myers Squibb Company · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Bristol-Myers Squibb's YERVOY (ipilimumab), approved for various cancers including melanoma, RCC, colorectal, hepatocellular, and NSCLC. It outlines dosage, administration, and recent labeling changes, notably the removal of the boxed warning for immune-mediated adverse reactions (IMARs) due to increased clinical experience and improved management. The report comprehensively covers YERVOY's safety profile, detailing incidence and severity of IMARs (diarrhea/colitis, hepatitis, dermatologic, endocrinopathies) as a single agent and in combination with nivolumab or vemurafenib across indications. Efficacy data from trials like CHECKMATE-227 and CHECKMATE-9LA for NSCLC, showing OS, PFS, and ORR, are also included, alongside immunogenicity data.
Key findings — cited to the page
| Immune-mediated hepatitis Grade 3 incidence | 4.9 % | · p.18 |
| Immune-mediated rash Grade 3-5 incidence | 2.5 % | · p.18 |
| Immune-mediated hepatitis Grade 3-5 incidence | 1.6 % | · p.17 |
| Immune-mediated hepatitis Grade 4 incidence | 1.2 % | · p.18 |
| Grade 3 increases in transaminases with or without concomitant increases in total bilirubin | 6 of 10 patients | · p.18 |
| Immune-mediated hepatitis Grade 3 incidence | 8 % | · p.17 |
| Immune-mediated diarrhea/colitis Grade 4 incidence | 1.5 % | · p.16 |
| Immune-mediated diarrhea/colitis Grade 3-5 incidence | 7 % | · p.16 |
| Immune-mediated diarrhea/colitis Grade 3 incidence | 4.4 % | · p.17 |
| Immune-mediated diarrhea/colitis Grade 3 incidence | 14 % | · p.16 |
| Immune-mediated hepatitis Grade 4 incidence | 2.8 % | · p.17 |
| Immune-mediated rash Grade 3 incidence | 4 % | · p.19 |
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 →