High-Risk Urothelial Carcinoma: Nivolumab Adjuvant Therapy FDA Approval
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
FDA Approval Announcement
- September 3, 2021
On August 19, 2021, the FDA approved nivolumab as adjuvant therapy for high-risk recurrence post-resection urothelial carcinoma. This represents the first FDA approval of adjuvant checkpoint inhibitor therapy for urothelial cancer.
CHECKMATE-274 Trial Design
Patient Population: High-risk recurrence urothelial carcinoma within 120 days post-resection (n randomized to 1:1)
Treatment Arms:
- Nivolumab 240 mg every 2 weeks (n=928)
- Placebo (n=928)
Primary Endpoint: Recurrence-free survival (disease-free survival)
Duration: Up to 1 year treatment
Key Efficacy Results
Recurrence-Free Survival (Intent-to-Treat):
- Nivolumab median RFS: 20.8 months
- Placebo median RFS: 10.8 months
PD-L1 Expression ≥1% Subgroup:
- Nivolumab median RFS: Not reached
- Placebo median RFS: 8.4 months
PD-L1 Negative Subgroup:
- Hazard ratio: 0.83 (non-stratified analysis)
Safety Profile
Adverse Events: >20 toxicities reported including rash, fatigue, diarrhea, pruritus, myalgia, urinary tract infection
Dosing and Administration
Recommended Dose: Nivolumab 240 mg every 2 weeks OR 480 mg every 4 weeks as adjuvant therapy
Treatment Duration: Up to 1 year
Data Source
FDA Approval: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-urothelial-carcinoma
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