Axatilimab：首次批准。

IF 13 1区医学 Q1 PHARMACOLOGY & PHARMACY Drugs Pub Date : 2024-11-18 DOI:10.1007/s40265-024-02109-1

Susan J Keam

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引用次数: 0

摘要

阿沙替利单抗（NIKTIMVO™；axatilimab-csfr）是一种抗集落刺激因子1受体（CSF-1R）人源化IgG4（κ轻链）单克隆抗体，由Incyte公司和Syndax制药公司共同开发，用于治疗慢性移植物抗宿主疾病（cGVHD）和其他适应症，包括特发性肺纤维化（IPF）。2024 年 8 月，阿沙替利单抗在美国获批用于治疗体重至少 40 千克的成人和儿童患者在既往接受至少两种系统疗法失败后出现的 cGVHD。2024年8月，阿昔利单抗被列入NCCN cGVHD指南。本文总结了阿沙替利单抗首次获批用于治疗cGVHD的发展里程碑。

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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Axatilimab: First Approval.

Axatilimab (NIKTIMVO™; axatilimab-csfr), an anti-colony-stimulating Factor 1 Receptor (CSF-1R) humanized IgG4 (κ light chain) monoclonal antibody, is being developed by Incyte Corporation and Syndax Pharmaceuticals for the treatment of chronic graft-versus-host disease (cGVHD) and other indications, including idiopathic pulmonary fibrosis (IPF). In August 2024, axatilimab was approved in the USA for the treatment of cGVHD after failure of at least two prior lines of systemic therapy in adult and paediatric patients weighing at least 40 kg. Axatilimab was added to the NCCN guidelines for cGVHD in August 2024. This article summarizes the development milestones leading to this first approval of axatilimab for the treatment of cGVHD.

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来源期刊

Drugs 医学-毒理学

CiteScore

22.70

自引率

0.90%

发文量

134

审稿时长

3-8 weeks

期刊介绍： Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.

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