{"title":"Rocbrutinib: First Approval.","authors":"Simon Fung","doi":"10.1007/s40265-026-02393-z","DOIUrl":null,"url":null,"abstract":"<p><p>Rocbrutinib (; LP-168) is a fourth generation Bruton's tyrosine kinase (BTK) inhibitor with both covalent and non-covalent modes of binding, which allow it to inhibit both wildtype as well as mutant variants of BTK. It is being developed by Lupeng Pharmaceuticals primarily as a treatment for patients with B-cell malignancies. Rocbrutinib received its first approval in June 2026 in China for use in adult patients with mantle cell lymphoma (MCL) that is relapsed or refractory to BTK inhibitors, and who have received ≥ 2 systemic therapies (including BTK inhibitors). This article summarizes the milestones in the development of rocbrutinib leading to its first approval in this indication.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":""},"PeriodicalIF":14.7000,"publicationDate":"2026-10-15","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/s40265-026-02393-z","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
Abstract
Rocbrutinib (; LP-168) is a fourth generation Bruton's tyrosine kinase (BTK) inhibitor with both covalent and non-covalent modes of binding, which allow it to inhibit both wildtype as well as mutant variants of BTK. It is being developed by Lupeng Pharmaceuticals primarily as a treatment for patients with B-cell malignancies. Rocbrutinib received its first approval in June 2026 in China for use in adult patients with mantle cell lymphoma (MCL) that is relapsed or refractory to BTK inhibitors, and who have received ≥ 2 systemic therapies (including BTK inhibitors). This article summarizes the milestones in the development of rocbrutinib leading to its first approval in this indication.
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.