Zai Lab secures China approval for Augtyro to treat NTRK fusion-positive solid tumors

CHINA—Zai Lab has achieved a significant regulatory milestone in China with the approval of Augtyro (repotrectinib) for the treatment of adult patients with solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

The National Medical Products Administration (NMPA) granted approval for the supplemental new drug application, marking an important expansion of the treatment’s availability in the country.

The approval specifically covers patients whose disease has spread to other parts of the body or has advanced locally.

It also applies to cases where surgical intervention could result in significant complications.

Patients eligible for this treatment must have experienced disease progression despite previous therapies or have no satisfactory alternative treatment options available.

The NMPA based its decision on compelling evidence from the TRIDENT-1 study, a pivotal Phase I/II clinical trial that demonstrated the drug’s effectiveness over time.

The study revealed that repotrectinib maintains durable efficacy while presenting a manageable safety profile for patients diagnosed with NTRK fusion-positive solid tumours.

Zai Lab played an active role in the global TRIDENT-1 study, administering the first dose to a patient in Greater China in May 2021.

This latest approval represents the second indication for Augtyro in China.

The NMPA previously granted approval for the drug in May 2024 to treat adult patients with locally advanced or metastatic ROS proto-oncogene 1 (ROS1)-positive non-small cell lung cancer (NSCLC).

The company now holds exclusive rights to develop and commercialize Augtyro across mainland China, Macau, Taiwan, and Hong Kong under a licensing agreement with Bristol Myers Squibb, which acquired Turning Point Therapeutics.

Dr. Rafael Amado, who serves as Zai Lab’s global research and development president and head, expressed satisfaction with the regulatory decision.

He emphasized that this approval addresses a critical treatment gap in the Chinese market, particularly because no prior therapy has received approval for both treatment-naïve patients and those who have previously received tyrosine kinase inhibitor (TKI) therapy within this patient population.

Dr. Amado further noted that the company anticipates this approval will help meet the substantial unmet medical needs of patients across the entire treatment spectrum.

The development follows the United States Food and Drug Administration’s approval of Augtyro in June 2024, which authorized the treatment for adult and pediatric patients aged 12 years and older with solid tumours featuring an NTRK gene fusion.

The successive approvals in major markets underscore the therapeutic potential of repotrectinib in addressing rare but serious oncological conditions characterized by specific genetic alterations.