Tunlametinib: First Approval.

IF 13 1区 医学 Q1 PHARMACOLOGY & PHARMACY Drugs Pub Date : 2024-08-01 Epub Date: 2024-07-22 DOI:10.1007/s40265-024-02072-x
Susan J Keam
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Abstract

Tunlametinib (®) is an oral, selective, mitogen-activated protein kinase kinase 1 and 2 (MEK 1/2) inhibitor being developed by Shanghai KeChow Pharma, Inc. for the treatment of solid tumours with RAS and RAF mutations, including melanoma, non-small cell cancer (NSCLC), colorectal cancer (CRC) and neurofibromatosis type 1 (NF1) plexiform neurofibromas. In March 2024, tunlametinib was granted conditional approval in China (based on surrogate endpoints) for use in patients with NRAS-mutated advanced melanoma who have failed anti-PD-1/PD-L1 treatment. This article summarizes the milestones in the development of tunlametinib leading to this first approval for the treatment of solid tumours with RAS and RAF mutations.

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通拉替尼(Tunlametinib):首次批准。
通拉替尼 (®)是上海科洲制药有限公司正在开发的一种口服、选择性丝裂原活化蛋白激酶激酶 1 和 2 (MEK 1/2)抑制剂,用于治疗 RAS 和 RAF 突变的实体瘤,包括黑色素瘤、非小细胞癌 (NSCLC)、结直肠癌 (CRC) 和神经纤维瘤病 1 型 (NF1) 丛状神经纤维瘤。2024 年 3 月,中国有条件批准 tunlametinib 用于抗 PD-1/PD-L1 治疗失败的 NRAS 突变晚期黑色素瘤患者(基于替代终点)。本文总结了曲拉米替尼开发过程中的里程碑事件,这些事件促成了曲拉米替尼首次获批用于治疗RAS和RAF突变的实体瘤。
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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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