Tagrisso (osimertinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

AstraZeneca AB. Tagrisso (osimertinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf. Revised July 2024. Accessed August 22, 2024.

Regulatory approvals

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

Indication Statements
TAGRISSO as monotherapy is indicated for the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA 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 as monotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. 1
TAGRISSO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. 1
TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. 4

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 oncogenic variants Non-Small Cell Lung Cancer Osimertinib
Sensitivity (+) EGFR p.T790M Non-Small Cell Lung Cancer Osimertinib
Sensitivity (+) EGFR Exon 19 (Deletion) Non-Small Cell Lung Cancer Cisplatin, Osimertinib
Sensitivity (+) EGFR Exon 19 (Deletion) Non-Small Cell Lung Cancer Carboplatin, Osimertinib
Sensitivity (+) EGFR p.L858R Non-Small Cell Lung Cancer Cisplatin, Osimertinib
Sensitivity (+) EGFR p.L858R Non-Small Cell Lung Cancer Carboplatin, Osimertinib