Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted accelerated approval to repotrectinib 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. The product label notes that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

This is written in the approval document as:

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.

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.

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