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On February 17, Zai Lab announced that the next-generation tyrosine kinase inhibitor (TKI) repotrectinib has been included in the breakthrough therapy category in China for patients with ROS1-positive metastatic non-small cell lung cancer who have not received ROS1 TKI therapy
According to public information, repotrectinib is a ROS1 and NTRK targeted inhibitor developed by Turning Point
Tumors with mutations in the ROS1 and NTRK genes are more likely to develop resistance to existing targeted therapies
It is reported that the inclusion of repotrectinib as a breakthrough therapy in China is based on preliminary data from global and Chinese TKI-naïve ROS1-positive non-small cell lung cancer (NSCLC) patients who participated in 1/2 of TRIDENT-1 period research
According to the public information of Zai Lab, in May 2021, the TRIDENT-1 study completed the first patient dosing in China
In October 2021, repotrectinib was granted breakthrough therapy designation by the FDA for the treatment of patients with advanced solid tumors harboring NTRK gene fusions
references:
[1] Zai Lab Announces Breakthrough Therapy Designation for Repotrectinib in China.
[2] Zai Lab Announces Repotrectinib Phase 2 Registration Study TRIDENT-1 Completed the First Patient Dosing in China.
