Tagrisso (osimertinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

AstraZeneca Canada Inc. Tagrisso (osimertinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080336.PDF. Revised April 2025. Accessed June 2025.

Regulatory approvals

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

Indication	Statements
TAGRISSO (osimertinib) is indicated as adjuvant therapy after tumour resection in patients with stage IB-IIIA1 non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.	2
TAGRISSO (osimertinib) is indicated for the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy.	2
TAGRISSO (osimertinib) is indicated for the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.	2
TAGRISSO (osimertinib) is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced (not amenable to curative therapies) or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.	4
TAGRISSO (osimertinib) is indicated for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Osimertinib
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Osimertinib
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Osimertinib
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Osimertinib
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Osimertinib
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Osimertinib
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Cisplatin, Osimertinib, Pemetrexed
Sensitivity (+)	EGFR p.L858R	Non-Small Cell Lung Cancer	Carboplatin, Osimertinib, Pemetrexed
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Carboplatin, Osimertinib, Pemetrexed
Sensitivity (+)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Cisplatin, Osimertinib, Pemetrexed
Sensitivity (+)	EGFR p.T790M	Non-Small Cell Lung Cancer	Osimertinib