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 cancer with a specific mutation rather than a specific cancer type.

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