On December 8, 2020 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported its lead drug candidate, repotrectinib, has been granted breakthrough therapy designation by the Food and Drug Administration (FDA) for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI-naïve) (Press release, Turning Point Therapeutics, DEC 8, 2020, View Source [SID1234572452]).

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"Breakthrough therapy designation is another milestone in our development of repotrectinib and one more step towards our goal to get this potentially important drug candidate to patients as quickly as possible," said Athena Countouriotis, M.D., president and chief executive officer. "I am incredibly proud of our Turning Point team with the achievement of our fourth regulatory designation from the FDA for repotrectinib, and pleased with how our enrollment specifically in the ROS1 TKI-naive population of the TRIDENT-1 study has progressed since we reported initial early Phase 2 data. We look forward to sharing more information on our overall study timelines early next year, and providing updated data from the TRIDENT-1 study next month."

Turning Point plans to present updated TRIDENT-1 Phase 2 study data from patients with TKI-naive ROS1-positive NSCLC during a mini-oral presentation at the World Conference on Lung Cancer on Jan. 31, 2021.

The breakthrough therapy designation for repotrectinib was supported by the initial data from TKI-naïve ROS1-positive NSCLC patients enrolled in the Phase 1 and Phase 2 portions of the TRIDENT-1 study, which is currently evaluating patients in multiple potentially registrational cohorts.

Breakthrough therapy designation is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. Repotrectinib was previously granted three Fast Track designations by the FDA, in ROS1-positive NSCLC patients who are TKI naïve, ROS1-positive NSCLC patients who have been previously treated with one prior platinum chemotherapy and one prior ROS1 TKI, and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs.