Zai Lab has received approval from China’s National Medical Products Administration (NMPA) for the supplemental new drug application (sNDA) for Augtyro (repotrectinib) to treat adult patients with solid tumours harbouring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
The approval applies to patients whose disease is metastatic or locally advanced, or where surgery may cause morbidity, and who have progressed on prior therapies or lack satisfactory alternatives.
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It was based on results from the pivotal Phase I/II TRIDENT-1 study, which showed repotrectinib’s durable efficacy, as well as a manageable safety profile in patients with NTRK fusion-positive solid tumours.
Zai Lab participated in the global TRIDENT-1 study and administered the initial dose to a patient in Greater China in May 2021.
In May 2024, the NMPA granted approval to Augtyro for treating adult patients with locally advanced or metastatic ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC).
Zai Lab holds exclusive rights to develop and commercialise Augtyro in mainland China, Macau, Taiwan, and Hong Kong through a licence agreement with Bristol Myers Squibb following its acquisition of Turning Point Therapeutics.
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By GlobalDataZai Lab global research and development president and head Dr Rafael Amado said: “We are pleased with the NMPA’s approval of Augtyro for patients with NTRK-positive solid tumours.
“This approval marks its second indication in China, addressing a critical treatment gap, as no prior therapy has been approved across both TKI-naïve and TKI-pretreated patients within this population. We believe this approval will help address the high unmet medical needs for patients across this treatment spectrum.”
In June 2024, the US Food and Drug Administration (FDA) approved Augtyro for treating adult and paediatric patients aged 12 years and older with solid tumours with an NTRK gene fusion.
