Zai Lab Announces NDA Acceptance of Repotrectinib for Patients with ROS1-positive NSCLC by China’s NMPA
SHANGHAI, China and CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
- SHANGHAI, China and CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
- “We are pleased to obtain the NMPA’s acceptance of our NDA for repotrectinib, which further supports repotrectinib as a potential best-in-class treatment for patients with ROS1-positive NSCLC in China.
- There is a significant unmet need for these patients given the limited durability of benefit, the emergence of resistance to approved therapies and eventual tumor progression,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
- “We look forward to collaborating with the NMPA during the review process in a joint effort to bring this important medicine to patients in need as soon as possible.”
In May 2023, the Center for Drug Evaluation (CDE) of China’s NMPA granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.