Zai Lab announces BTD granted for repotrectinib

Zai Lab announced that the Center for Drug Evaluation, CDE, of the National Medical Products Administration, NMPA, granted Breakthrough Therapy Designation, BTD, for investigational repotrectinib for the treatment of patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with TRK tyrosine kinase inhibitors. The Breakthrough Therapy Designation for repotrectinib was supported by data from both global and Chinese NTRK-positive TKI-pretreated patients enrolled in the Phase 1/2 TRIDENT-1 study. “We are excited to receive our fourth Breakthrough Therapy Designation for repotrectinib in China. Today’s recognition further supports repotrectinib as a potential first-in-class treatment for patients with NTRK-positive, TKI-pretreated solid tumors in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab. “NTRK is estimated to be an oncogenic driver in approximately 0.5 percent of patients with a variety of advanced solid tumors.1 There remains an unmet medical need for NTRK-positive, TKI-pretreated advanced solid tumor 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.”