FDA grants accelerated approval for BMS’ Augtyro in NTRK

The US Food and Drug Administration (FDA) yesterday granted accelerated approval to Augtyro (repotrectinib), from Bristol Myers Squibb (NYSE: BMY), for a new indication.

This authorization is for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.

This marks the drug's second indication after gaining US approval for ROS1-positive non-small-cell lung cancer (NSCLC) last November. Chinese regulators also recently cleared the drug in this indication.