This article has been updated to clarify Augtyro's eligible patient population.
NEW YORK – The US Food and Drug Administration on Thursday granted accelerated approval to Bristol Myers Squibb's Augtyro (repotrectinib) as a treatment for certain patients with solid tumors harboring NTRK gene fusions.
The agency approved Augtyro for adult and pediatric patients at least 12 years old with NTRK-postive solid tumors that are locally advanced or metastatic or where surgical resection is likely to cause severe morbidity, and that have progressed on treatment or have no satisfactory alternative therapy.
"The FDA approval of repotrectinib adds an important tool to our toolbox, offering oncologists a next-generation [tyrosine kinase inhibitor] that can be used across a broad range of NTRK fusion-positive solid tumors for both TKI-naïve and TKI-pretreated patients," Alexander Drilon, chief of the early drug development service at Memorial Sloan Kettering Cancer Center and global lead for the pivotal TRIDENT-1 trial, said in a statement.
The FDA based its decision on the results of the Phase I/II TRIDENT-1 trial, in which 88 patients received Augtyro. Of these patients, 48 had received prior TRK inhibitors and 40 had not. Among those who had not received TRK inhibitors before, the overall response rate was 58 percent and the median duration of response was not reached at data cutoff. In patients who had received prior TRK inhibitors, the overall response rate was 50 percent and the median duration of response was 9.9 months.
The FDA has approved two other TRK inhibitors in a tissue-agnostic fashion: Bayer's Vitrakvi (larotrectinib) and Genentech's Rozlytrek (entrectinib).
Augtyro is designed to inhibit both TRK and ROS1. In November, based on the activity seen in another cohort in TRIDENT-1, BMS nabbed FDA approval for Augtyro as a treatment for advanced ROS1-altered non-small cell lung cancer.
The drugmaker brought Augtyro into its pipeline when it acquired Turning Point Therapeutics for $4.1 billion in 2022.