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# Turning Point Breakthrough Status for Lung Cancer Drug
- URL: https://www.fdaweb.com/turning-point-breakthrough-status-for-lung-cancer-drug/
- Published: 2020-12-08T12:00:00.000Z
- Updated: 2026-09-14T16:39:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148255

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.