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FDA Approves Bristol Myers Squibb's Augtyro in NTRK-Positive Refractory Solid Tumors

NEW YORK – The US Food and Drug Administration on Thursday granted accelerated approval to Bristol Myers Squibb's Augtyro (repotrectinib) as a treatment for patients with refractory solid tumors harboring NTRK gene fusions. 

The agency granted tissue-agnostic approval to the TRK inhibitor, indicating it for patients who are at least 12 years old, have any type of advanced solid tumor, and are out of treatment options. To be eligible for Augtyro, patients must have progressed on prior treatments and be ineligible for surgical resection.

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.