FDA accepts Augtyro sNDA for priority review in NTRK

The US Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Augtyro (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity.

US pharma major Bristol Myers Squibb (NYSE: BMY) gained rights to repotrectinib along with its acquisition of US cancer drug developer Mirati Therapeutics (Nasdaq: MRTX), in a $4.8 billion deal, with a further $1 billion contingent.

The latest approval adds to the FDA authorization last November for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer NSCLC.