Turning Point Secures Positive FDA Feedback For Planned Lung Cancer Drug Submission

Turning Point Therapeutics 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

Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsHealth CareFDAGeneralBiotechnologyFDA Pre-NDA MeetingHealth Care
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!