ZLAB - Zai Lab gets priority review for lung cancer dug repotrectinib in China

2023-05-18 08:50:29 ET

• China's National Medical Products Administration (NMPA) granted priority review to Zai Lab's ( NASDAQ: ZLAB ) repotrectinib to treat adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
• A priority status helps expedite the review and approval timelines.
• "The CDE’s decision to grant priority review to repotrectinib underscores repotrectinib as a potential next-generation best-in-class treatment for ROS1-positive NSCLC in both TKI-naïve and pretreated patients in China," said Rafael Amado, president, head of Global Oncology Research and Development at Zai.
• Repotrectinib, a tyrosine kinase inhibitor (TKI), is being evaluated by Bristol Myers Squibb ( BMY ) and Zai in a phase 1/2 trial called TRIDENT-1 in adults and a phase 1/2 study, dubbed, CARE in children.
• In April, Foundation Medicine said it expanded collaboration with Bristol Myers to develop a tissue-based test FoundationOne CDx, as a companion diagnostic for the oral cancer drug repotrectinib.
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