Posted by Michael Wonder on 13 Jun 2024
FDA grants accelerated approval to repotrectinib for adult and paediatric patients with NTRK gene fusion positive solid tumours
13 June 2024 - Today, the FDA granted accelerated approval to repotrectinib (Augtyro, BMS) for adult and paediatric patients 12 years and older with solid tumours 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.
Efficacy was evaluated in TRIDENT-1, a multi-centre, single-arm, open-label, multi-cohort trial in 88 adult patients with locally advanced or metastatic NTRK gene fusion positive solid tumours who had either received a prior TRK tyrosine kinase inhibitor (n=48) or were TKI-naïve (n=40).
