Augtyro (repotrectinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Bristol-Myers Squibb. Augtyro (repotrectinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218213s001lbl.pdf. Revised June 2024. Accessed October 30, 2024.

Regulatory approvals

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

Indication	Statements
AUGTYRO is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).	1
AUGTYRO is a kinase inhibitor indicated for the treatment of adult and pedatric patients 12 years of age and older with solid tumors that (i) have a neutrophic tyrosine receptor kinase (NTRK) gene fusion and (ii) are locally advanced or metastatic or where surgical resection is likely to result in severe morbility, and (iii) have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.	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