Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) whose tumour has epidermal growth factor receptor (EGFR) exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations.

This is written in the approval document.

Reimbursement

CDS

Citation

Osimertinib Monotherapy, 2024, version number 5, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6914/353_V5_Osimertinib_Monotherapy.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Osimertinib
HSE (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Osimertinib

Contributions

Date	Contributor	Description
2024-03-01	Health Service Executive	Indication approved for reimbursement.
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database