FDA decisions on new oncological drugs

Tsinghua Clinical Research Institute (GL, YL, XC), Center for Regulatory Sciences (RH), School of Medicine, Tsinghua University, Beijing, China; Yeehong Business School, Shenyang Pharmaceutical University, Shenyang, China (LS); Office of Clinical Trial Institute, Beijing Tsinghua Changgung Hospital, Beijing, China (XC) Importing oncology trials from China: a bridge over troubled waters?On Feb 10, 2022, the US Food and Drug Administration's Oncologic Drugs Advisory Committee will convene to discuss ORIENT-11, a clinical trial comparing chemotherapy plus sintilimab, an anti-PD-1 monoclonal antibody and member of the checkpoint inhibitor class, with chemotherapy alone as an initial treatment for metastatic non-small-cell lung cancer (NSCLC).1 Done exclusively in China, the trial's design, patient population, and statistical analysis closely resembles landmark NSCLC trials that established checkpoint inhibitors as part of initial treatment regimens several years ago. Full-Text PDF FDA decisions on new oncological drugs*David J Benjamin, Vinay Prasad, Mark P Lythgoe Full-Text PDF