China’s National Medical Products Administration’s Center for Drug Evaluation has granted breakthrough therapy designation to Zai Lab’s repotrectinib for treating patients with NTRK-positive advanced solid tumours.
The designation is based on the data from the first-in-human, open-label, multi-centre Phase I/II TRIDENT-1 study in adults.
This registrational study is being carried out with Turning Point Therapeutics, acquired by Bristol Myers Squibb.
Zai Lab took part in the study in Greater China (mainland China, Hong Kong, Taiwan, and Macau) while Turning Point is enrolling patients globally.
Almost 500 pretreated participants aged 12 years and above with NTRK-positive TRK tyrosine kinase inhibitors (TKI) received oral repotrectinib.
The primary outcome measures of the study include dose-limiting toxicities, a recommended Phase II dose and the overall response rate.
Zai Lab global oncology research and development head and president Rafael Amado stated: “We are excited to receive our fourth breakthrough therapy designation for repotrectinib in China.
“NTRK is estimated to be an oncogenic driver in approximately 0.5% of patients with a variety of advanced solid tumours. There remains an unmet medical need for NTRK-positive, TKI-pretreated advanced solid tumour patients where there are no targeted therapies currently approved.
“We look forward to working with regulatory authorities in China to bring this important medicine to patients in need as soon as possible.”