Turning Point Therapeutics (NASDAQ:TPTX) has received positive feedback from the U.S. Food and Drug Administration (FDA) at a pre-New Drug Application (NDA) meeting completed in the second quarter.
The pre-NDA meeting was convened to discuss its planned NDA for the lead asset Repotrectinib in the treatment of ROS1+ advanced non-small cell lung cancer (NSCLC).
Repotrectinib is being evaluated in the TRIDENT-1 registrational study in patients with ROS1+ advanced non-small cell lung cancer (NSCLC)
The agency has agreed with the company's plan to provide data for ROS1+ TKI-naïve and TKI-pretreated advanced NSCLC patients with at least six months of follow-up from the first post-baseline scan at the time of NDA submission.
Mohammad Hirmand, M.D., Chief Medical Officer, commented: ”We continue to be encouraged by our collaborative meetings with the FDA. The planned NDA submission represents an important milestone for our company. The unmet need in ROS1+ advanced NSCLC patients is significant, and we continue to believe that repotrectinib could offer a best-in-class profile for the treatment of these patients."
Price Action : Turning Point shares closed Wednesdays trading at $75.04