Posted by Michael Wonder on 14 Feb 2024
US FDA accepts for priority review Bristol Myers Squibb’s application for Augtyro (repotrectinib) for the treatment of patients with NTRK positive locally advanced or metastatic solid tumours
14 February 2024 - The US FDA assigned a target action date of 15 June 2024.
Bristol Myers Squibb today announced that the US FDA has accepted the supplemental new drug application for Augtyro™ (repotrectinib) for the treatment of adult and paediatric patients 12 years of age and older with solid tumours 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.
