Turning Point Therapeutics, Inc. TPTX received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for its lead drug candidate Repotrectinib in Patients With One Prior ROS1 Tyrosine Kinase Inhibitor and no Prior Chemotherapy.
The designation grant was supported by efficacy analyses of 50 patients pooled from the Phase 1 and Phase 2 portions of the TRIDENT-1 study.
Mohammad Hirmand, M.D., Chief Medical Officer, stated, “We are encouraged by the continued momentum in TRIDENT-1 with enrollment targets achieved in cohorts EXP-1, EXP-4 and EXP-6. We look forward to continuing to progress repotrectinib toward registration with our first pre-NDA meeting with the FDA to discuss the topline data by blinded independent central review from the ROS1-positive advanced NSCLC cohorts of the TRIDENT-1 study expected later this quarter.”
This grant marks the company’s eighth regulatory designation, and third Breakthrough Therapy designation.
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.
Turning Point Therapeutics closed Monday’s trading down 9 percent at $24.32
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