Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for reimbursement as a treatment option for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma with tumor cell programmed death ligand 1 (PD-L1) expression >= 1%. This regimen specifically cites cisplatin and 5-fluorouracil as the chemotherapy. It also notes that, as the platinum and fluoropyrimidine based chemotherapy is not defined in the EMA licensed indication, other evidence-based platinum and fluoropyrimidine regimens may be used in combination with nivolumab.
This is written in the approval document as:
Nivolumab in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell programmed death ligand 1 (PD-L1) expression >= 1%.
Reimbursement
Incomplete Reimbursement
Nivolumab - ODMS; Oxaliplatin, 5-Flourouracil - N/A
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | PD-L1 >= 1% | Esophageal Squamous Cell Carcinoma | Fluorouracil, Nivolumab, Oxaliplatin |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-01-16 | Van Allen lab | Adding HSE approvals for reimbursement to database |
| 2023-07-01 | Health Service Executive | Indication approved for reimbursement. |