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Turning Point Therapeutics, Inc. (NASDAQ:TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, today announced receipt of positive feedback from the U.S. Food and Drug Administration (FDA) at a pre-New Drug Application (NDA) meeting completed within the second quarter. The feedback focused on the planned patient follow-up within the ROS1+ advanced non-small cell lung cancer (NSCLC) patient cohorts of the ongoing TRIDENT-1 registrational study of repotrectinib, the company’s lead drug candidate, which is a potential best-in-class ROS1 tyrosine kinase inhibitor that has received two breakthrough therapy designations within ROS1+ advanced NSCLC.
The purpose of the pre-NDA meeting was to discuss the company’s planned NDA for repotrectinib for the treatment of ROS1+ advanced NSCLC. The FDA 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.
“We continue to be encouraged by our collaborative meetings with the FDA,” said Mohammad Hirmand, M.D., Chief Medical Officer. “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.”
Posted In: TPTX
