Regulatory approval

Published by the Health Canada.

Health Canada approved osimertinib 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.

This is written in the approval document as:

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.

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.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) EGFR p.T790M Non-Small Cell Lung Cancer Osimertinib