Turning Point Breakthrough Status for Lung Cancer Drug

FDA has granted Turning Point Therapeutics a breakthrough therapy designation for repotrectinib and its use in treating patients with gene ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI). The designation was based on positive data from the company’s TRIDENT-1 study. Updated data from the study is expected next month, it says. Repotrectinib was previously granted three fast track designations by FDA — in ROS1-positive NSCLC patients who are TKI naive, ROS1-positive NSCLC patients who have been previously treated with one prior platinum chemotherapy and one prior ROS1 TKI, and neurotrophic tyrosine receptor kinase-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TKIs.