Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized repotrectinib for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).

This is written in the approval document as:

AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC)

Citation

Bristol-Myers Squibb Pharma EEIG. Augtyro (repotrectinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/augtyro-epar-product-information_en.pdf. Revised January 2025. Accessed September 8, 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	v::ROS1	Non-Small Cell Lung Cancer	Repotrectinib

Contributions

Date	Contributor	Description
2025-09-08	Van Allen lab	On 2025-01-28, the EMA provided conditional approval to Augtyro (repotrectinib) for two treatment indications: (i) adult patients with ROS1-positive non-small cell lung cancer, or (ii) adults and pediatric patients aged 12 and older with solid tumors that have an NTRK gene fusion.
2025-01-13	European Medicines Agency	Indication received approval from the European Commission.