05:40 PM EDT, 06/13/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said late Thursday the US Food and Drug Administration granted accelerated approval of Augtyro, or repotrectinib, to treat solid tumors in adult and pediatric patients 12 years and older.

The regulator's approval was based on the overall response rate and duration of response in the phase 1/2 Trident-1 study, the drugmaker said.

For those who haven't received a previous therapy, 58% of patients had a confirmed objective response rate, with a median follow-up of nearly 18 months. Of the responding patients, 83% were still in response at one year with Augtyro. The median duration of response hasn't been reached yet, the company said.

In pre-treated patients, the confirmed objective response rate was 50%, with a median follow-up of more than 20 months. Forty-two percent of responding patients were still in response at one year with Augtyro. The median duration of response was 9.9 months, the company said.