Tarceva (erlotinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Roche Registration GmbH. Tarceva (erlotinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tarceva-epar-product-information_en.pdf. Revised May 2023. Accessed March 23, 2024.

Regulatory approvals

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

Indication	Statements
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.	1
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	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	EGFR oncogenic variants	Non-Small Cell Lung Cancer	Erlotinib
Sensitivity (+)	EGFR oncogenic variants	Non-Small Cell Lung Cancer	Erlotinib