Lisaftoclax：第一次批准。

IF 14.4 1区医学 Q1 PHARMACOLOGY & PHARMACY

Drugs Pub Date : 2025-10-08 DOI:10.1007/s40265-025-02251-4

Yahiya Y Syed

{"title":"Lisaftoclax：第一次批准。","authors":"Yahiya Y Syed","doi":"10.1007/s40265-025-02251-4","DOIUrl":null,"url":null,"abstract":"Lisaftoclax is a B-cell lymphoma 2 (BCL-2) inhibitor developed by Ascentage Pharma for the treatment of haematological malignancies. It is administered using a 5-day ramp-up schedule, reaching the target dose on day 6. Lisaftoclax received its first approval on 10 July 2025 in China for the treatment of chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who had received at least one prior systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. This article summarizes the milestones in the development of lisaftoclax leading to this first approval for CLL/SLL.","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.4000,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Lisaftoclax: First Approval.\",\"authors\":\"Yahiya Y Syed\",\"doi\":\"10.1007/s40265-025-02251-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Lisaftoclax is a B-cell lymphoma 2 (BCL-2) inhibitor developed by Ascentage Pharma for the treatment of haematological malignancies. It is administered using a 5-day ramp-up schedule, reaching the target dose on day 6. Lisaftoclax received its first approval on 10 July 2025 in China for the treatment of chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who had received at least one prior systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. This article summarizes the milestones in the development of lisaftoclax leading to this first approval for CLL/SLL.\",\"PeriodicalId\":11482,\"journal\":{\"name\":\"Drugs\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":14.4000,\"publicationDate\":\"2025-10-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drugs\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40265-025-02251-4\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drugs","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40265-025-02251-4","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}

引用次数: 0

摘要

Lisaftoclax是一种b细胞淋巴瘤2 （BCL-2）抑制剂，由Ascentage制药公司开发，用于治疗血液系统恶性肿瘤。使用5天的增加计划给药，在第6天达到目标剂量。Lisaftoclax于2025年7月10日在中国首次获得批准，用于治疗至少接受过一种全身治疗（包括布鲁顿酪氨酸激酶（BTK）抑制剂）的成人慢性淋巴细胞性白血病（CLL）或小淋巴细胞性淋巴瘤（SLL）。本文总结了lisaftoclax首次获得CLL/SLL批准的开发过程中的里程碑。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Lisaftoclax: First Approval.

Lisaftoclax is a B-cell lymphoma 2 (BCL-2) inhibitor developed by Ascentage Pharma for the treatment of haematological malignancies. It is administered using a 5-day ramp-up schedule, reaching the target dose on day 6. Lisaftoclax received its first approval on 10 July 2025 in China for the treatment of chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who had received at least one prior systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. This article summarizes the milestones in the development of lisaftoclax leading to this first approval for CLL/SLL.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

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.