The FDA granted accelerated approval to repotrectinib for the treatment of adults and children 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion.
The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors.
Alexander Drilon, MD, highlights how the approval of repotrectinib addresses the need for improved therapies for patients who have progressed on a previous TKI and delves into notable neurologic toxicities seen with the agent.