ZLAB - Zai Lab drug gets 2 breakthrough therapy tags in China to treat lung cancer subtype

China's National Medical Products Administration granted two breakthrough therapy designations to Zai Lab's (NASDAQ:ZLAB) repotrectinib to treat certain patients with non-small cell lung cancer (NSCLC). The designation for the drug is to treat patients with ROS1-positive metastatic NSCLC who have received one prior line of ROS1 tyrosine kinase inhibitor (TKI) and one prior treatment with platinum-based chemotherapy (EXP-2); and for those whose NSCLC has spread to other parts and test positive for a fusion in the ROS1 gene and have received one prior line of ROS1 TKI and no chemotherapy or immunotherapy (EXP-4). The company said the designations were backed by data from a phase 1/2 trial called TRIDENT-1. "Since repotrectinib received Breakthrough Therapy Designation by the CDE earlier this year for ROS1-positive TKI-naïve patients, today’s recognition further supports repotrectinib as a potential best-in-class treatment for ROS1-positive NSCLC in both TKI-naïve and pretreated patients in China," said Alan Sandler, president and head of Global Development, Oncology at Zai Lab.

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Zai Lab drug gets 2 breakthrough therapy tags in China to treat lung cancer subtype