TPTX - Turning Point Therapeutics' lead candidate nabs accelerated review for lung cancer

The FDA has designated Turning Point Therapeutics' ([[TPTX]] +7.0%) repotrectinib a Breakthrough Therapy status 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.Repotrectinib is being studied in Phase 2 study called TRIDENT-1 in adults and a Phase 1/2 study in pediatric TKI-naive ROS1-positive NSCLC patients; the company plans to present updated TRIDENT-1 data at the World Conference on Lung Cancer in January.Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

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Turning Point Therapeutics' lead candidate nabs accelerated review for lung cancer