Turning Point Therapeutics Provides Regulatory Update for Repotrectinib for the Treatment of ROS1+ Advanced NSCLC
28 Jul 2022
CollaborateBreakthrough TherapyADC
SAN DIEGO, July 27, 2022 (GLOBE NEWSWIRE) -- 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+ advancedNSCLC. 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.”
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes elzovantinib, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer; and TPX-4589 (LM-302), a novel ADC targeting Claudin18.2 being studied in a Phase 1 study in gastrointestinal cancers. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.
Organizations
Indications
Targets
Drugs
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.