Bristol Myers says FDA accepts sNDA for Augtyro

Bristol Myers Squibb announced that the U.S. FDA has accepted the supplemental New Drug Application for Augtyro for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, and are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity. The filing acceptance is based on results from the registrational Phase 1/2 TRIDENT-1 trial and CARE study. The FDA granted the application Priority Review status and assigned a Prescription Drug User Fee Act goal date of June 15, 2024.