Zai Lab Limited (ZLAB) said that the National Medical Products Administration or NMPA in China has approved the New Drug Application (NDA) for AUGTYRO (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (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-nave and TKI-pretreated patients with ROS1-positive NSCLC.
In June 2023, China's NMPA accepted the NDA for AUGTYRO for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC, with priority review granted in May 2023.
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