Regulatory approval

Published by the European Medicines Agency.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::NTRK1	Any solid tumor	Repotrectinib
Sensitivity (+)	v::NTRK2	Any solid tumor	Repotrectinib
Sensitivity (+)	v::NTRK3	Any solid tumor	Repotrectinib