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Repotrectinib capsules approved with conditions for marketing by China NMPA

CCFDIE|Updated: 2024-05-11

     

Recently, the Class 1 innovative drug Repotrectinib Capsules (trade name: 奥凯乐/AUGTYRO) of Bristol-Myers Squibb Company is approved for marketing with conditions through the priority review and approval procedure by China NMPA. The product is indicated for adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Repotrectinib is a tyrosine kinase inhibitor that targets the ROS1 oncogene and the tropomyosin receptor kinases (TRKs), including TRKA, TRKB and TRKC. The marketing of this drug provides new treatment options for adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer.