The Center for Drug Evaluation (CDE) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB) repotrectinib is on track to receive priority review status in China for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ROS1-positive. This priority review status is a reflection of the drug’s breakthrough therapy designation (BTD) and conditional approval channel status for the indication, highlighting its potential significance in cancer treatment.
Repotrectinib: A Next-Generation ROS1/TRK/ALK Tyrosine Kinase Inhibitor
Repotrectinib is a next-generation ROS1/TRK/ALK tyrosine kinase inhibitor (TKI) that was originally developed by Turning Point Therapeutics Inc. In July 2020, Zai Lab secured a USD 176 million licensing deal with the US firm, acquiring exclusive development and commercialization rights to the drug in Greater China.
Breakthrough Therapy Designations and Orphan Drug Designation
In June 2022, repotrectinib was awarded BTD statuses for use in ROS1 positive metastatic NSCLC patients who have previously received frontline ROS1 TKI+ chemotherapy and those who have previously received one frontline ROS1 TKI and have not received chemotherapy or immunotherapy. The drug has obtained three BTD statuses and four fast-track statuses in the US, covering various patient groups with ROS1 positive advanced NSCLC and advanced solid tumor patients who have previously received one or two frontline TRK TKI treatments. Additionally, repotrectinib has received orphan drug designation (ODD) from the US FDA, recognizing the drug’s potential to address rare diseases.-Fineline Info & Tech
