Regulatory approval

Published by the European Medicines Agency.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::ROS1	Non-Small Cell Lung Cancer	Repotrectinib