Regulatory approval

Published by the Health Canada. Approved

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.

This is written in the approval document.

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.

Therapeutic response

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

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