Turning Point Therapeutics Inc. (NASDAQ: TPTX) has announced that it has received a seventh regulatory designation for its lead product candidate, repotrectinib, from the FDA.
Repotrectinib was given Breakthrough Therapy designation
The company received a Breakthrough Therapy designation was given for repotrectinib in treating patients with advanced solid tumors having an NTRK gene fusion that has progressed after one or two previous TRK tyrosine kinase inhibitors, without or with prior chemotherapy and having no viable alternative treatments. Turning Point plans to meet the FDA to discuss the next steps regarding possible repotrectinib registration.
CEO and President Athena Countouriotis said, “We are excited to receive our second Breakthrough Therapy designation and seventh overall regulatory designation for repotrectinib. There remains an unmet medical need for NTRK-positive, TKI-pretreated advanced solid tumor patients where there are no targeted therapies currently approved. We look forward to presenting additional clinical data from our TRIDENT-1 study of repotrectinib during the AACR-NCI-EORTC conference later this week, including a late-breaker plenary presentation where early clinical data from the NTRK EXP-5 and EXP-6 cohorts will be discussed.”
The FDA grants Breakthrough Therapy Designation to accelerate development and regulatory review for experimental drugs for the treatment of serious and life-threatening conditions. Notably, the criteria for the designation require initial clinical evidence to show that the medicine could have considerable improvement on more than one clinically significant endpoint relative to available therapy.
Repotrectinib has four Fast-Track designations
So far, repotrectinib has Breakthrough Therapy designation in ROS1-positive metastatic NSCLC patients that are yet to receive treatment with ROS1 tyrosine kinase inhibitor. It also has Fast-Track Designations in ROS1+ advanced NSCLC patients that are ROS1 TKI naïve, pretreated ROS1+ Advanced NSCLC patients with a previous ROS1 TKI with any platinum-based chemo, those that have received a previous platinum-based line of therapy or one previous ROS1 TKI and NTRK+ patients with advanced solid tumors that have advanced after a previous chemotherapy line or at least one previous TRK TKIS.