Augtyro Approved for Adult and Pediatric Patients With NTRK Gene Fusion-Positive Solid Tumors

The FDA has granted accelerated approval to repotrectinib (Augtyro, Bristol Myers Squibb) for adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic, for which surgical resection is likely to result in severe morbidity, and that have progressed after treatment or have no satisfactory alternative therapy.

Efficacy was evaluated in TRIDENT-1 (ClinicalTrials.gov. Identifier: