On January 6, 2025, Nuvalent, Inc. announced that its independently developed taletrectinib has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), regardless of prior treatment with ROS1 tyrosine kinase inhibitors (TKIs). Pursuant to an exclusive licensing agreement, Innovent Biologics will commercialize and promote taletrectinib in mainland China under the brand name DOVBLERON, and the product was officially launched in China in January 2025. Previously, taletrectinib had been granted Breakthrough Therapy Designation and Priority Review status by the NMPA.
Basis for This Approval
The approval from the NMPA is based on data from the pivotal Phase II TRUST-I study of taletrectinib conducted in Chinese patients. The results of this study have been published in the Journal of Clinical Oncology and were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024.
Notably, in December 2024, the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for taletrectinib submitted by Nuvalent, Inc., which seeks approval for the indication of advanced ROS1-positive non-small cell lung cancer, regardless of treatment line.
The FDA has granted Priority Review to this application, with a Prescription Drug User Fee Act (PDUFA) target review date of June 23, 2025. Taletrectinib has previously been granted Orphan Drug Designation, and it is also the only investigational ROS1 tyrosine kinase inhibitor to have received Breakthrough Therapy Designation from the FDA for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, regardless of prior treatment with ROS1 tyrosine kinase inhibitors.
The U.S. New Drug Application is supported by pooled analysis results from the pivotal Phase II TRUST-I and TRUST-II studies of taletrectinib, which were presented at the European Society for Medical Oncology (ESMO) Congress in September 2024.
About Taletrectinib
Taletrectinib is an oral, potent, brain-penetrant, and highly selective next-generation ROS1 inhibitor specifically developed for the treatment of patients with advanced ROS1-positive non-small cell lung cancer. Currently, two pivotal Phase II single-arm clinical trials are evaluating its therapeutic efficacy in this patient population: the TRUST-I study conducted in China ([ClinicalTrials.gov](ClinicalTrials.gov) Identifier: NCT04395677) and the global TRUST-II study ([ClinicalTrials.gov](ClinicalTrials.gov) Identifier: NCT04919811).
The FDA has granted Breakthrough Therapy Designation to taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer, regardless of prior treatment with ROS1 tyrosine kinase inhibitors, and has also granted Orphan Drug Designation for the treatment of ROS1-positive non-small cell lung cancer and other non-small cell lung cancer indications. Based on the pooled analysis results from the TRUST-I and TRUST-II clinical studies, the FDA has accepted and granted Priority Review to the New Drug Application for taletrectinib submitted by Nuvalent, Inc., which seeks full approval for the treatment of patients with advanced ROS1-positive non-small cell lung cancer, regardless of treatment line.
About ROS1-Positive Non-Small Cell Lung Cancer
Over one million new cases of non-small cell lung cancer are diagnosed globally each year, making it the most common histological subtype of lung cancer. Approximately 2% of non-small cell lung cancer patients are estimated to be ROS1-positive. Up to 35% of patients initially diagnosed with metastatic ROS1-positive non-small cell lung cancer present with brain metastases, and this proportion rises to 55% among patients who experience disease progression following initial treatment. Despite advances in the treatment of ROS1-positive non-small cell lung cancer in recent years, there remains a significant unmet clinical need for more effective and better-tolerated therapeutic options.
