Augtyro (repotrectinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
AUGTYRO as monotherapy is indicated for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC)	1
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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::ROS1	Non-Small Cell Lung Cancer	Repotrectinib
Sensitivity (+)	v::NTRK1	Any solid tumor	Repotrectinib
Sensitivity (+)	v::NTRK2	Any solid tumor	Repotrectinib
Sensitivity (+)	v::NTRK3	Any solid tumor	Repotrectinib