Pre-NDA to CDE of NMPA submitted in China for asandeutertinib (TY-9591)
This Pre-NDA submission is based on the outstanding results of the TYKM1601202 study (ESAONA), a prospective, multicenter, randomized, active-controlled, pivotal registrational study. The study aimed to evaluate the efficacy and safety of asandeutertinib compared to osimertinib in first-line treatment of NSCLC patients with brain metastases. Led by Professor Yuankai Shi of the Cancer Hospital of the Chinese Academy of Medical Sciences, the study involved a total of 53 centers, including Shandong Cancer Hospital and Hunan Cancer Hospital. For more details on the study, please refer to clinicaltrials.gov, NCT05948813.
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