Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized repotrectinib for the treatment of adult and pediatric patients 12 years of age and older with advanced solid tumors expression NTRK gene fusions, and (i) who have received a prior NTRK inhibitor, or (ii) have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinial benefit, or have been exhausted.

This is written in the approval document as:

AUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumors expression NTRK gene fusions, and (i) who have received a prior NTRK inhibitor, or (ii) have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinial benefit, or have been exhausted.

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::NTRK1	Any solid tumor	Repotrectinib
EMA (1)	v::NTRK2	Any solid tumor	Repotrectinib
EMA (1)	v::NTRK3	Any solid tumor	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.