Regulatory approval

Published by the Health Canada.

Health Canada approved osimertinib 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.

This is written in the approval document as:

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.

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.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