Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved durvalumab for reimbursement as a monotherapy treatment option 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).

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).

Citation

Durvalumab Monotherapy 1500 mg - 28 day, 2023, version number 3, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/655-durvalumab-1500mg-monotherapy-28-day.pdf

Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) PD-L1 >= 1% Non-Small Cell Lung Cancer Durvalumab