# Osimertinib

Osimertinib (Tagrisso, AstraZeneca AB) has 5 EU-approved indications in 1 tumour type. Each needs a biomarker result: EGFR (5).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| EGFR exon 19 deletions or exon 21 (L858R) | Monotherapy | Adjuvant | After complete tumour resection; Stage IB-IIIA |
| EGFR exon 19 deletions or exon 21 (L858R) | + pemetrexed and platinum-based chemotherapy | 1st line, advanced | - |
| EGFR mutation | Monotherapy | 1st line, advanced | - |
| EGFR exon 19 deletions or exon 21 (L858R) | Monotherapy | Consolidation, locally advanced | After platinum-based chemoradiation therapy without disease progression; Unresectable; disease has not progressed during or following platinum-based chemoradiation therapy |
| EGFR T790M | Monotherapy | Advanced | - |

## Products

### Tagrisso

- Company: AstraZeneca AB
- Target: EGFR tyrosine kinase inhibitor
- Class: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
- ATC: L01EB04
- EU approval: 1 Feb 2016
- Label revised: 18 Aug 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tagrisso-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tagrisso

Mechanism (SmPC section 5.1): Osimertinib is an irreversible inhibitor of epidermal growth factor receptors (EGFR) harboring sensitising mutations and the T790M resistance mutation.

## Label wording

- **Osimertinib** (Tagrisso), Non-small cell lung cancer, adjuvant: “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 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)
- **Osimertinib** (Tagrisso), Non-small cell lung cancer, consolidation, locally advanced: “the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)
- **Osimertinib** (Tagrisso), Non-small cell lung cancer, 1st line, advanced: “the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)
- **Osimertinib** (Tagrisso), Non-small cell lung cancer, advanced: “the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)
- **Osimertinib** (Tagrisso), Non-small cell lung cancer, 1st line, advanced: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tagrisso-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/osimertinib