Regulatory approval

Published by the European Medicines Agency. Approved

TAGRISSO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

This is written in the approval document.

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 January 2025. Accessed September 5, 2025.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
EMA (1) EGFR p.T790M Non-Small Cell Lung Cancer Osimertinib