Tuesday, November 27, 2018 – The U.S. Food and Drug Administration (FDA) granted accelerated approval to larotrectinib (VITRAKVI, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with advanced solid tumors, including lung cancer, that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known resistance mutation. These gene fusions can be in the NTRK1, NTRK2, or NTRK3 genes. Patients with advanced lung cancer who had NTRK gene fusions were included in the research that led to this approval.
This is the second time the FDA has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. This approval highlights the importance of molecular testing/biomarker testing for advanced lung cancer.