Overall Survival and the Evolving Benefit-Risk Assessment for Poly (ADP-ribose) Polymerase Inhibitors in Advanced Ovarian Cancer.

IF 42.1 1区 医学 Q1 ONCOLOGY
Journal of Clinical Oncology Pub Date : 2025-07-01 Epub Date: 2025-05-19 DOI:10.1200/JCO-24-02834
Mirat Shah, Ting-Yu Chen, Gwynn Ison, Mallorie H Fiero, Hui Zhang, Xin Gao, Marc Neilson, Kirsten B Goldberg, Abhilasha Nair, Tiffany K Ricks, William F Pierce, Nicole Gormley, Marc R Theoret, Shenghui Tang, Richard Pazdur, Paul G Kluetz, Laleh Amiri-Kordestani
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引用次数: 0

Abstract

From 2014 through 2019, the US Food and Drug Administration (FDA) granted approval to six indications for poly (ADP-ribose) polymerase (PARP) inhibitors in advanced epithelial ovarian cancer (EOC). From 2022 through 2023, these six indications were withdrawn or narrowed after observation of a potential detrimental effect on overall survival (OS) in four randomized controlled trials. The indications for niraparib, olaparib, and rucaparib for the treatment of BRCA-mutated or homologous recombination deficiency-positive advanced EOC were withdrawn. The indications for niraparib, olaparib, and rucaparib for the maintenance treatment of recurrent EOC were narrowed to only patients with BRCA mutations. Recognizing the clinical implications of these regulatory actions, herein we describe the FDA's decision-making process and the rationale behind the removal or narrowing of these indications for PARP inhibitors in advanced EOC. Furthermore, this article provides insight into the FDA's interpretation of potential OS detriments and subgroup analyses to shape regulatory decisions.

晚期卵巢癌中聚(adp -核糖)聚合酶抑制剂的总生存期和不断变化的获益-风险评估。
从2014年到2019年,美国食品和药物管理局(FDA)批准了六种用于晚期上皮性卵巢癌(EOC)的聚(adp -核糖)聚合酶(PARP)抑制剂的适应症。从2022年到2023年,在四项随机对照试验中观察到对总生存期(OS)的潜在有害影响后,这六种适应症被撤销或缩小。撤销了尼拉帕尼、奥拉帕尼和鲁卡帕尼治疗brca突变或同源重组缺陷阳性晚期EOC的适应症。尼拉帕尼、奥拉帕尼和鲁卡帕尼用于复发性EOC维持治疗的适应症被缩小到只有BRCA突变的患者。认识到这些监管行动的临床意义,本文描述了FDA的决策过程以及在晚期EOC中取消或缩小PARP抑制剂这些适应症的基本原理。此外,本文还提供了FDA对潜在OS危害的解释和亚组分析,以形成监管决策。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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