FDA Expands Entrectinib Indication in Pediatric Patients With NTRK+ Solid Tumors
October 20th 2023
The FDA has granted accelerated approval to entrectinib (Rozlytrek) for pediatric patients aged older than 1 month with solid tumors that harbor a 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 after treatment or have no satisfactory standard therapy options.