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BMS Seeking US Approval for Augtyro in Adult, Pediatric Patients With NTRK-Positive Tumors

NEW YORK – The US Food and Drug Administration has accepted Bristol Myers Squibb's supplemental new drug application (sNDA) seeking approval for its ROS1 and TRK inhibitor Augtyro (repotrectinib) as a treatment for adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion, the firm said on Wednesday.

The FDA granted priority review to the sNDA and is expected to make an approval decision by June 15. BMS is seeking approval in patients 12 years of age and older where surgical resection of their tumor is likely to result in severe morbidity.

The application was based on data from the Phase I/II TRIDENT-1 trial in adult patients and the CARE trial in pediatric patients. Results from the TRIDENT-1 trial showed that Augtyro led to a response in 58 percent of patients with NTRK-positive tumors, including lung, salivary gland, thyroid, soft tissue sarcoma, and others. The trial also showed efficacy in patients who had prior tyrosine kinase inhibitor treatment and those who had acquired resistance mutations.

Results from the CARE trial have not yet been reported, but BMS said the TRIDENT-1 data were supported by data from the CARE study. The Phase I/II trial is enrolling pediatric and young adult patients with locally advanced or metastatic solid tumors harboring ALK, ROS1, or NTRK1-3 gene alterations.

"While great advancements have been made over the last decade, patients with NTRK-positive locally advanced or metastatic solid tumors still experience significant unmet needs," Joseph Fiore, global program lead for Augtyro at Bristol Myers Squibb, said in a statement. "New and effective treatment options that may improve durability of response and address resistance to existing tyrosine kinase inhibitors are critical to helping patients with these aggressive tumors."

Augtyro was approved in the US in November for the treatment of advanced non-small cell lung cancer patients whose tumors harbor ROS1 gene alterations. That approval was based on another cohort from the TRIDENT-1 trial.

BMS gained the rights to Augtyro when it bought the drug's developer, Turning Point Therapeutics, in a $4.1 billion deal in 2022.