China’s NMPA Has Granted Taletrectinib (ROS1 Inhibitor) Priority Review Designation, said AnHeart Therapeutics and Innovent.
Innovent Biologics Inc. ("Innovent") is a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology, and other major diseases, and AnHeart Therapeutics ("AnHeart").
Taletrectinib is a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer; a next-generation ROS1 tyrosine kinase inhibitor (TKI) used to treat adult patients with locally progressed or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously received ROS1 TKI treatment. The NDA was accepted by the CDE in November 2023.
"Taletrectinib's potential as a best-in-class precision therapy is further underscored by the Priority Review Designation," said Dr. Hui Zhou, Senior Vice President of Innovent. We will continue to collaborate with regulatory authorities to support the taletrectinib evaluation, with the goal of delivering this next-generation innovation which is an alternative to China to meet unmet needs for ROS1-positive NSCLC patients."
"Taletrectinib's Priority Review Designation reinforces the urgent need for patients with ROS1-positive NSCLC who were previously treated with ROS1 TKIs in China, as well as the significant clinical advance that taletrectinib may represent for these patients," said Bing Yan, MD, Chief Medical Officer of AnHeart. We look forward to collaborating with regulatory authorities as they conduct their review of taletrectinib in order to bring this groundbreaking investigational medication to patients as soon as feasible."
In China, the NDA and Priority Review Designation are based on results from the Phase 2 TRUST-I study (NCT04395677). The results of an interim TRUST-I analysis were presented at the European Lung Cancer Congress (ELCC) 2023. Concerning ROS1-positive Lung Cancer of the Non-Small Cell Type
About Taletrectinib
Taletrectinib is a strong, brain-penetrant, selective, next-generation potential best-in-class ROS1 inhibitor that is taken orally. Taletrectinib is being tested in two Phase 2 trials in ROS1-positive NSCLC patients: TRUST-I (NCT04395677) in China and TRUST-II (NCT04919811) globally.
Taletrectinib was granted Breakthrough Therapy Designation by the CDE of China's NMPA in March 2022 for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who had previously been treated with ROS1 TKIs as well as those who had never been treated with ROS1 TKIs (TKI-naive).
Taletrectinib has also been designated as a Breakthrough Therapy in the United States by the Food and Drug Administration (FDA) for the treatment of ROS1-positive NSCLC.
Innovent and AnHeart signed an exclusive licence agreement in June 2021 for the co-development and commercialization of taletrectinib in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan.