Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized osimertinib for treatment of adult patients with locally advanced or metastatic EGFR p.T790M mutation-positive non-small cell lung cancer.
This is written in the approval document as:
TAGRISSO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
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 p.T790M | Non-Small Cell Lung Cancer | Osimertinib |