On April 21, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that China’s National Medical Products Administration (NMPA) has accepted the supplemental New Drug Application (sNDA) for repotrectinib for the treatment of adult patients with solid tumors that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion (Press release, Zai Laboratory, APR 21, 2025, View Source [SID1234652006]). The application is intended for patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options.
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"NTRK fusion-positive tumors represent a significant therapeutic challenge, particularly in the setting of acquired resistance to existing TRK tyrosine kinase inhibitors (TKIs)," said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "There are no approved treatments for NTRK-positive cancers for both TKI-naïve and TKI-pretreated patients in China. Repotrectinib has the potential to become a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors in both settings."
In February 2025, China’s NMPA granted priority review to repotrectinib for the treatment of adult patients with advanced solid tumors that have an NTRK gene fusion.
About Repotrectinib
Repotrectinib is a next-generation tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers. Patients with solid tumors, including NSCLC, harboring ROS1 and NTRK gene fusions treated with approved targeted therapies often develop resistance mutations that limit binding of these drugs to their target. Ultimately, this leads to shortened duration of response and tumor progression. Repotrectinib is the first next-generation ROS1 and TRK TKI uniquely designed to improve durability of benefit, including in the brain, and to address acquired resistance.
In June 2024, AUGTYRO (repotrectinib) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
In May 2024, AUGTYRO was approved by the NMPA for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC). It was approved by the FDA for this indication in November 2023.
Zai Lab has an exclusive license agreement with Turning Point Therapeutics, Inc. (a Bristol Myers Squibb company) to develop and commercialize AUGTYRO in Greater China (mainland China, Hong Kong, Taiwan, and Macau, collectively).
About NTRK-Positive Solid Tumors
NTRK-positive advanced malignancies are life-threatening with poor prognoses and represent an area of significant unmet medical need in adult and pediatric patients. Existing targeted therapies have demonstrated clinical benefits but are limited by the duration of response due to the emergence of acquired resistance mutations.1 In China, there was no approved treatment option for NTRK-positive cancers that was studied in both TKI-naïve and TKI-pretreated patients across solid tumors.
1 Harada G, Santini FC, Wilhelm C, Drilon A, et al. NTRK fusions in lung cancer: From biology to therapy. Lung Cancer. 2021;161:108-113.