cilta-cel的国际批准：CAR - T细胞调控的镜头

IF 82.2 1区医学 Q1 ONCOLOGY

Nature Reviews Clinical Oncology Pub Date : 2025-02-06 DOI:10.1038/s41571-025-00996-1

Chenghao Ge, Chen Yin, Xiaoyuan Chen

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引用次数: 0

摘要

靶向bcma嵌合抗原受体（CAR） T细胞疗法ciltacabtagene autoleucel （cilta-cel）在全球开展的研究中显示出卓越的疗效，已在40个国家获得监管机构批准。在此，我们研究了导致其在不同地区获得批准的监管途径，重点关注临床开发和监管提交中的挑战，并为推进创新细胞疗法的策略提供见解。

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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International approvals of cilta-cel: a lens on CAR T cell regulation

The BCMA-targeted chimeric antigen receptor (CAR) T cell therapy ciltacabtagene autoleucel (cilta-cel) has demonstrated exceptional efficacy in studies conducted worldwide, which has resulted in regulatory approvals in >40 countries. Herein, we examine the regulatory pathways that led to its approval in different regions, focus on challenges in clinical development and regulatory submission, and provide insight into strategies for advancing innovative cell therapies.

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来源期刊

Nature Reviews Clinical Oncology 医学-肿瘤学

CiteScore

99.40

自引率

0.40%

发文量

114

审稿时长

6-12 weeks

期刊介绍： Nature Reviews publishes clinical content authored by internationally renowned clinical academics and researchers, catering to readers in the medical sciences at postgraduate levels and beyond. Although targeted at practicing doctors, researchers, and academics within specific specialties, the aim is to ensure accessibility for readers across various medical disciplines. The journal features in-depth Reviews offering authoritative and current information, contextualizing topics within the history and development of a field. Perspectives, News & Views articles, and the Research Highlights section provide topical discussions, opinions, and filtered primary research from diverse medical journals.