Tarlatamab:首次批准。

IF 13 1区 医学 Q1 PHARMACOLOGY & PHARMACY
Drugs Pub Date : 2024-08-01 Epub Date: 2024-07-18 DOI:10.1007/s40265-024-02070-z
Sohita Dhillon
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引用次数: 0

摘要

Tarlatamab(tarlatamab-dlle:IMDELLTRA™)是安进公司正在开发的第一类半衰期延长的双特异性δ样配体3(DLL3)导向CD3 T细胞吸引剂,用于治疗小细胞肺癌(SCLC)和神经内分泌性前列腺癌。Tarlatamab 可与肿瘤细胞表面的 DLL3 和细胞毒性 T 淋巴细胞(CTL)表面的 CD3 结合,从而激活 T 细胞、释放炎性细胞因子,并使表达 DLL3 的肿瘤细胞在 CTL 的介导下死亡。2024 年 5 月,tarlatamab 首次获得美国批准,用于治疗铂类化疗期间或之后疾病进展的广泛期 SCLC(ES-SCLC)成人患者。根据关键性 2 期 DeLLphi-301 研究的总反应率和反应持续时间,Tarlatamab 加速获得了该适应症的批准。巴西、加拿大、以色列和英国正在对 Tarlatamab 进行监管审查,多个国家正在开展临床研究。本文总结了塔拉他单抗开发过程中的里程碑事件,这也是该药首次获批用于铂类化疗或化疗后疾病进展的 ES-SCLC 治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Tarlatamab: First Approval.

Tarlatamab: First Approval.

Tarlatamab (tarlatamab-dlle: IMDELLTRA™) is a first-in-class, half-life extended bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager being developed by Amgen for the treatment of small cell lung cancer (SCLC) and neuroendocrine prostate cancer. Tarlatamab binds to DLL3 on the surface of tumour cells and CD3 on the surface of cytotoxic T lymphocytes (CTLs), resulting in T-cell activation, release of inflammatory cytokines and CTL-mediated cell death of DLL3-expressing tumour cells. In May 2024, tarlatamab received its first approval in the USA for the treatment of adults with extensive stage SCLC (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Tarlatamab received accelerated approval for this indication based on overall response rate and duration of response in the pivotal phase 2 DeLLphi-301 study, and continued approval may be contingent on the demonstration of clinical benefit in a confirmatory trial(s). Tarlatamab is under regulatory review in Brazil, Canada, Israel and the UK, and clinical studies are underway in multiple countries. This article summarizes the milestones in the development of tarlatamab leading to this first approval for ES-SCLC with disease progression on or after platinum-based chemotherapy.

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来源期刊
Drugs
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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