Repotrectinib was again awarded the breakthrough therapy title for the treatment of ROS1-positive metastasis NSCLC

Turning Point Therapeutics Inc. announced on December 8 that its candidate drug for ROS1-positive metastasis non-small cell lung cancer (NSCLC), which has not been treated with ROS1 tyrosine kinase inhibitors (TKI-naïve), has been named a breakthrough treatment by the U.S. Food and Drug Administration (FDA).
the breakthrough therapy was supported by initial data on TKI-naïve ROS1-positive NSCLC patients included in TRIDENT-1 Studies I and II, which are currently evaluating patients in multiple potential registration queues.
Willing Point plans to present an oral presentation at the World Lung Cancer Congress on January 31, 2021, providing updated TRIDENT-1 study data for TKI-naïve ROS1-positive NSCLC patients.
Repotrectinib is a new generation of broad-spectrum kinase inhibitors that inhibit the activity of ROS1, TRK, and ARK, and has previously been granted three fast-track licenses by the FDA for ROS1-positive metastasis non-small cell lung cancer that has not been treated with tyrosine kinase inhibitors.
ros1-positive NSCLC patients who had received one platinum-containing drug chemotherapy and one ROS1 tyrosine kinase inhibitor.
patients with NTRK-positive advanced solid tumors who progressed after receiving first-line chemotherapy and 1 to 2 TRK inhibitors.
this breakthrough therapy recognition is another milestone in the development of Repotrectinib and the fourth time regulators have identified an important step toward helping the drug's ultimate goal of being market.
Domestically, Turning Point acquired The exclusive development and commercialization rights to Reprectinib in Greater China (Chinese mainland, Hong Kong, Macau and Taiwan) in July this year through a joint effort with Redding Pharmaceuticals to enter the Chinese market, with cash payments of $25 million and potential development, registration and sales-based milestone payments and royalty rates of up to $151 million.
, according to the announcement of Reding Pharmaceuticals, will carry out relevant research in China for Thetrident-1 Clinical Phase II trial of Repotrectinib.
In addition to Repotrectinib's inhibitors for ROS1, TRK, and ARK-positive non-small cell lung cancer and advanced solid tumors, the other drug candidate product lines include: TPX-0022, with met, CSF1R, and SRC base targets, corresponding to a Phase I clinical study called SHIELD-1, in patients with advanced or metastasis tumors with MET mutations.
TPX-0046, RET inhibitor, is currently in phase I/II clinical studies, the patients in the group are RET-positive patients with advanced or metastases.
TPX-0131, ALK inhibitor, is currently in the process of applying for a new drug.
source: Turning Point Therapeutics Granted FDA File Therapy Designation for Repotrectinib Treatment in Patients with ROS1-Positive Metastatic-Small Cell Cell Cancer