Balasubramaniam Sanjeeve, Kim Geoffrey S, McKee Amy E, Pazdur Richard
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Cancer. 2017 Jul 15;123(14):2604-2608. doi: 10.1002/cncr.30652. Epub 2017 May 12.
Ovarian cancer remains a disease entity that is responsible for considerable morbidity and mortality among women worldwide. Modern drug research pipelines and accelerated drug development timelines applied to other disease entities have begun to make an impact on treatment options for patients with advanced ovarian cancer, as exemplified by the recent accelerated approval of 2 agents for this disease as the forerunners of a growing number of registrational trials. Regulatory flexibility for this serious and life-threatening condition spurs the consideration of intermediate endpoints for regulatory trial design, including potential applications in the development of newer therapeutic classes such as targeted therapies and immunotherapies for patients with advanced ovarian cancer. Cancer 2017;123:2604-8. © 2017 American Cancer Society.
卵巢癌仍然是一种在全球范围内导致女性出现相当高发病率和死亡率的疾病实体。应用于其他疾病实体的现代药物研发渠道和加速的药物开发时间表已开始对晚期卵巢癌患者的治疗选择产生影响，最近有两种药物因该病获得加速批准，成为越来越多注册试验的先行者，便是例证。针对这种严重且危及生命的疾病的监管灵活性促使人们在监管试验设计中考虑采用中间终点，包括其在开发针对晚期卵巢癌患者的新型治疗类别（如靶向疗法和免疫疗法）中的潜在应用。《癌症》2017年；123:2604 - 8。© 2017美国癌症协会
