# Erlotinib

Erlotinib (Tarceva, Cheplapharm Registration GmbH) has 5 EU-approved indications in 2 tumour types. 3 need a biomarker result: EGFR (3).

## Approved indications

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| EGFR mutation | Monotherapy | 1st line, advanced | - |
| EGFR mutation | Monotherapy | Maintenance, advanced | Stable disease after first-line chemotherapy |
| EGFR mutation | Monotherapy | 2nd line, advanced | After failure of at least one prior chemotherapy regimen |
| EGFR negative | Monotherapy | 2nd line, advanced | After failure of at least one prior chemotherapy regimen; When other treatment options are not considered suitable |

### Pancreatic cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + gemcitabine | Metastatic | - |

## Products

### Tarceva

- Company: Cheplapharm Registration GmbH
- Target: EGFR tyrosine kinase inhibitor
- Class: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
- ATC: L01EB02
- EU approval: 19 Sep 2005
- Label revised: 5 Mar 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/tarceva-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/tarceva

Mechanism (SmPC section 5.1): Erlotinib binds the ATP-binding site of EGFR, inhibiting its intracellular phosphorylation and downstream signaling to halt cell proliferation and induce apoptosis.

## Label wording

- **Erlotinib** (Tarceva), Non-small cell lung cancer, 1st line, advanced: “Tarceva is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating mutations.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf)
- **Erlotinib** (Tarceva), Non-small cell lung cancer, maintenance, advanced: “Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf)
- **Erlotinib** (Tarceva), Non-small cell lung cancer, 2nd line, advanced: “Tarceva is also indicated for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf)
- **Erlotinib** (Tarceva), Non-small cell lung cancer, 2nd line, advanced: “In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf)
- **Erlotinib** (Tarceva), Pancreatic cancer, metastatic: “Tarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tarceva-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/erlotinib