Osimertinib Monotherapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

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

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).	1
First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.	1
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
HSE (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Osimertinib
HSE (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Osimertinib
HSE (1)	EGFR p.T790M	Non-Small Cell Lung Cancer	Osimertinib
HSE (1)	EGFR activating variants	Non-Small Cell Lung Cancer	Osimertinib