Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved durvalumab as a monotherapy for reimbursement as a treatment option for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors express PD-L1 >= 1% on tumor cells and whose disease has not progressed following platinum-based chemo-radiation therapy (CRT).

This is written in the approval document as:

As monotherapy is indicated for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 >= 1% on tumour cells and whose disease has not progressed following platinum-based chemo-radiation therapy (CRT)

Reimbursement

ODMS

Citation

Durvalumab Monotherapy 10mg/kg - 14 Day, 2025, version number 4a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6888/576_V4a_Durvalumab.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Durvalumab

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2021-02-01	Health Service Executive	Indication approved for reimbursement.