国家药监局：批准英飞凡成为用于治疗局限期小细胞肺癌的单药

Core Insights - AstraZeneca announced that Imfinzi (durvalumab) has been approved by the National Medical Products Administration of China for the treatment of adult patients with limited-stage small cell lung cancer (SCLC) who have not progressed after platinum-based chemoradiotherapy [2][3] - The approval is based on positive results from the ADRIATIC Phase III clinical trial, which demonstrated a 27% reduction in the risk of death compared to placebo [2] - Limited-stage SCLC is a highly aggressive type of lung cancer with a poor prognosis, where only 15% to 30% of patients survive beyond five years post-diagnosis [2] Clinical Trial Results - The ADRIATIC trial showed significant overall survival benefits for patients treated with durvalumab, with a three-year overall survival rate of 57% [2] - This marks durvalumab as the first and only immunotherapy option for limited-stage SCLC in decades, potentially establishing a new treatment standard in China and globally [2] Future Directions - AstraZeneca plans to continue focusing on patient-centered approaches, leveraging its R&D capabilities, and enhancing external collaborations to provide innovative treatment options [2] - The approval is expected to not only revolutionize the treatment landscape for limited-stage SCLC but also improve the prognosis for all stages of small cell lung cancer patients [3]