Posted by Michael Wonder on 20 Oct 2023
FDA expands paediatric indication for entrectinib and approves new pellet formulation
20 October 2023 - Today, the FDA granted accelerated approval to entrectinib (Rozlytrek, Genentech) for paediatric patients older than 1 month with solid tumours that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy.
In August 2019, FDA granted accelerated approval to entrectinib for paediatric patients 12 years of age and older for this indication.
