The U.S. Food and Drug Administration (FDA) has approved Augtyro (repotrectinib) for treating patients aged 12 and older with locally advanced or metastatic solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions.
Augtyro’s approval stems from the Phase 1/2 TRIDENT-1 trial, which evaluated its efficacy in patients with NTRK-positive solid tumors. The results demonstrated clinically meaningful response rates in both TKI-naïve and TKI-pretreated patients.
In TKI-naïve patients, Augtyro exhibited a confirmed objective response rate (cORR) of 58%, with 43% achieving partial responses and 15% complete responses. Among TKI-pretreated patients, the cORR was 50%, with 50% achieving partial responses.
Notably, Augtyro has shown activity in patients with measurable central nervous system (CNS) metastases, with intracranial responses observed in TKI-naïve and TKI-pretreated patients.
Augtyro’s use carries certain Warnings & Precautions, including potential central nervous system effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal fractures, and embryo-fetal toxicity.
This approval represents a significant advance in treating patients with NTRK-positive tumors, offering a targeted therapy option for both TKI-naïve and TKI-pretreated patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.