Regulatory approval
Published by the Health Service Executive.
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)
Citation
Durvalumab Monotherapy 10mg/kg - 14 Day, 2023, version number 4, NCCP National SACT Regimen, NCCP, viewed 04/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/lung/576.pdfTherapeutic 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 |