Bristol-Myers' Augtyro Receives Priority Review Status From FDA

(RTTNews) - Bristol-Myers Squibb Company (BMY) announced on Wednesday that the FDA has accepted the supplemental New Drug Application for Augtyro also known as repotrectinib, and has given the application Priority Review status and set a Prescription Drug User Fee Act goal date of June 15, 2024. The filing acceptance is supported by data from the Phase 1/2 TRIDENT-1 trial and CARE study, which focused on adult and pediatric patients with NTRK-positive solid tumors, respectively.

The Augtyro drug treats adult and pediatric patients aged 12 and above with solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.