ROZLYTREK® (Entrectinib)

The FDA on October 20, 2023, granted accelerated approval to ROZLYTREK® for pediatric patients older than 1 month 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, FDA granted accelerated approval to ROZLYTREK® for pediatric patients 12 years of age and older for this indication. ROZLYTREK® is a product of Genentech Inc.