Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved tislelizumab in combination with FOLFOX-6 modified therapy (5-fluorouracil, folinic acid, and oxaliplatin) as a treatment option for the first-line treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express programmed death-ligand (PD-L1) with a tumor area positivity (TAP) score >= 5%. The treatment regimen further states 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 tislelizumab.

This is written in the approval document as:

First-line treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) whose tumours express programmed death-ligand (PD-L1) with a tumour area positivity (TAP) score >= 5%.

Reimbursement

Incomplete Reimbursement

Tislelizumab - ODMS; oxaliplatin and 5-fluorouracil - N/A

Citation

Tislelizumab and FOLFOX-6 Modified Therapy, 2026, version number 1, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/7462/Tislelizumab_and_FOLFOX-6_Modified_Therapy.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 (TAP) >= 5%	Esophageal Squamous Cell Carcinoma	Fluorouracil, Oxaliplatin, Tislelizumab

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2025-11-01	Health Service Executive	Indication approved for reimbursement.