用于治疗肾细胞癌的贝佐替凡：在监管批准与社会和患者影响之间取得平衡。
Belzutifan for renal cell carcinoma: Balancing regulatory approval with societal and patient impact.
作者信息
Chahoud Jad, Msaouel Pavlos
机构信息
Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Department of Genitourinary Oncology, UT MD Anderson Cancer Center, Houston, TX, USA.
出版信息
Med. 2025 Jan 10;6(1):100563. doi: 10.1016/j.medj.2024.11.016.
LITESPARK-005 evaluated belzutifan against everolimus in advanced renal cell carcinoma (RCC), demonstrating significant progression-free survival improvement but failing to meet the overall survival (OS) co-primary endpoint. Despite FDA approval, the trial highlights key obstacles in drug development in RCC, given the absence of OS improvement, lack of biomarker studies, high financial toxicity, and limited accessibility outside the United States.
LITESPARK-005研究评估了belzutifan与依维莫司用于晚期肾细胞癌（RCC）的疗效，结果显示无进展生存期有显著改善，但未达到总生存期（OS）这一共同主要终点。尽管获得了美国食品药品监督管理局（FDA）的批准，但鉴于缺乏总生存期的改善、缺乏生物标志物研究、高经济毒性以及在美国境外的可及性有限，该试验凸显了肾细胞癌药物研发中的关键障碍。
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