Zai Lab, Turning Point’s Solid Tumor Treatment Repotrectinib Gets FDA Breakthrough Therapy Designation

China-based Zai Lab and Turning Point Therapeutics announced that the FDA has granted a breakthrough therapy designation to repotrectinib, which is the seventh regulatory designation repotrectinib got from USFDA.

Repotrectinib is a potential treatment for advanced solid tumor patients with an NTRK gene fusion. It has been treated with one or two prior TRK tyrosine kinase inhibitors, with or without prior chemotherapy, and those have no alternative treatments.

What Is Repotrectinib?

Repotrectinib, developed by Turning Point, is a macrocyclic tyrosine kinase inhibitor of ROS1, TRK, and ALK. The treatment can firmly bind to the ATP binding pocket of active kinase, preventing the structural mutations resulting in drug resistance.

According to the Phase 1/2 trial TRIDENT-1 reported in 2020, using repotrectinib to treat ROS1-positive advanced non-small cell lung cancer (NSCLC) patients demonstrated a positive objective response rate (ORR) of 93% with acceptable tolerability. 

The preliminary results also led the FDA to grant repotrectinib a Breakthrough Therapy Designation in patients with ROS1-positive metastatic NSCLC who were TKI-naïve.

Recent Collaboration between Zai Lab and Turning Point Therapeutics

In 2020 July, Turning Point out-licensed the development and commercial right of repotrectinib to Zai Lab in Great China. Turning Point received $176 million in the license deal. 

In 2021 January, the two companies broadened their cooperation with a deal worth $361 million, under which Zai Lab gained the exclusive right to develop Turning Point’s TPX-0022, an oncology drug candidate for MET/SRC/CSF1R inhibitor.

Author

Kathy Huang

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