Zai Lab's Repotrectinib Earns Breakthrough Designation in China for NTRK-Positive Tumors
Zai Lab Limited has announced the granting of Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA). This designation applies to the investigational drug repotrectinib, which is intended for the treatment of advanced solid tumors characterized by NTRK gene fusions. These tumors have progressed following prior treatment with TRK tyrosine kinase inhibitors (TKIs).
The approval of Breakthrough Therapy Designation is based on comprehensive data obtained from both global and Chinese patients who have NTRK-positive TKI-pretreated tumors and participated in the Phase 1/2 TRIDENT-1 study. This designation further underscores the potential of repotrectinib as an innovative treatment option for patients in China with NTRK-positive, TKI-pretreated solid tumors.
The Breakthrough Therapy Designation review process is designed to expedite the development and evaluation of new medicines aimed at preventing or treating severe, life-threatening diseases or conditions that significantly impact the quality of life, especially in cases where no effective treatments currently exist, or when there is substantial evidence indicating the superiority of the new drug over existing options. Drugs granted Breakthrough Therapy Designation benefit from enhanced communication and guidance from the CDE to accelerate the drug development process.
Repotrectinib is an advanced tyrosine kinase inhibitor that targets ROS1 and NTRK oncogenic drivers in advanced solid tumors, including non-small cell lung cancer (NSCLC). Patients with tumors harboring ROS1 and NTRK gene fusions, who have received approved targeted therapies, often develop resistance mutations, leading to disease progression. Repotrectinib represents the first next-generation TKI for metastatic NSCLC with ROS1-positive mutations and tumors characterized by NTRK fusions. It has been uniquely designed to counteract critical drivers of disease progression, demonstrating significant anti-tumor activity and durable responses in both treatment-naïve and pre-treated patients.
