FDA Expands Pediatric Indication for Rozlytrek and Approves New Pellet Formulation

The FDA granted accelerated approval to entrectinib (Rozlytrek, Genentech) for pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) 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, the FDA granted accelerated approval to entrectinib for