Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized osimertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating EGFR variants.

This is written in the approval document as:

TAGRISSO as monotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.

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.

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	Osimertinib