ROZLYTREK® (Entrectinib)

The FDA on August 15, 2019 granted accelerated approval to ROZLYTREK® for adults and pediatric patients 12 years of age and older 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. ROZLYTREK® is a product of Genentech Inc.