Zai Lab announced that the National Medical Products Administration, or NMPA, in China has approved the new drug application, or NDA, for Augtyro for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer, or NSCLC. The approval is based on the pivotal TRIDENT-1 study, an open-label, single-arm, Phase 1/2 trial that evaluated repotrectinib in TKI-naive and TKI-pretreated patients with ROS1-positive NSCLC.
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