Therapeutic Response

v::NTRK3 status confers therapeutic sensitivity to Repotrectinib in patients with Any solid tumor.

Statements

Source and description
Augtyro (repotrectinib) [package insert]. FDA. 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.
Augtyro (repotrectinib) [product information]. EMA. 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.