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

IF 81.1 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

引用次数: 0

Abstract

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.