Turning Point gets third FDA Breakthrough Therapy tag for repotrectinib for a NSCLC indication

May 10, 2022 9:24 AM ETTurning Point Therapeutics, Inc. (TPTX)By: Anuron Mitra, SA News Editor

Lung cancer. lung disease. 3d illustration

Mohammed Haneefa Nizamudeen/iStock via Getty Images

  • Turning Point Therapeutics (NASDAQ:TPTX) on Tuesday said the U.S. Food and Drug Administration (FDA) granted a third Breakthrough Therapy designation to the company's lead drug candidate repotrectinib for the treatment of non-small cell lung cancer (NSCLC) in a certain, specific indication.
  • The Breakthrough Therapy designation was granted for the treatment of patients with ROS1-positive metastatic NSCLC who have been previously treated with one ROS1 tyrosine kinase inhibitor and who have not received prior platinum-based chemotherapy.
  • The Breakthrough Therapy designation is also the eight overall regulatory designation from the FDA for repotrectinib.
  • TPTX stock lost 9.3% on Monday. It had added 6.1% in premarket trade on Tuesday.

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