Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized erlotinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR activating variants. Erlotinib's production information further states that factors associated with prolonged survival should be taken into account when prescribing erlotinib. It further states that no survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC negative tumors.

This is written in the approval document as:

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.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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