FDA Approves Genentech’s Rozlytrek (entrectinib) for ROS1 Non-Small Cell Lung Cancer (NSCLC) and NTRK-Driven Tumors

2019-08-16T10:54:48-05:00August 16th, 2019|Hot Topics, News|

On August 15, 2019 the U.S. Food and Drug Administration approved Rozlytrek (entrectinib) for the treatment of patients with ROS1-positive, metastatic non-small cell lung cancer. It was also simultaneously approved for the treatment of patients with any solid tumor that is NTRK fusion-positive, following progression on other therapies. This approval offers a new targeted therapy option for patients with both of these rare mutations and is only the third time that the FDA has approved a targeted therapy for any [...]

FDA Approves Targeted Therapy for Solid Tumors with NTRK Gene

2020-02-11T09:11:22-06:00November 27th, 2018|Hot Topics, News|

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 [...]