Rozlytrek® (entrectinib) – Expanded indication, new formulation approval
October 20, 2023 - The FDA announced the accelerated approval of Genentech’s Rozlytrek (entrectinib), for the treatment of adult and pediatric patients older than 1 month of age with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, as detected by an FDA-approved test 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 alternative therapy.
Top