{"title":"Linvoseltamab: First Approval.","authors":"Arnold Lee","doi":"10.1007/s40265-025-02207-8","DOIUrl":null,"url":null,"abstract":"<p><p>Linvoseltamab (Lynozyfic™) is a human B cell maturation antigen (BCMA)×cluster of differentiation (CD) 3 bispecific antibody that binds to both BCMA and CD3 to direct T cells against malignant B cells. Linvoseltamab is being developed by Regeneron Pharmaceuticals, Inc. for multiple indications including multiple myeloma and received its first approval on 28 Apr 2025 in the EU. This article summarises the milestones in the development of linvoseltamab leading to this first approval in the EU as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥ 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.</p>","PeriodicalId":11482,"journal":{"name":"Drugs","volume":" ","pages":"1329-1333"},"PeriodicalIF":14.4000,"publicationDate":"2025-10-01","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/s40265-025-02207-8","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/29 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Linvoseltamab (Lynozyfic™) is a human B cell maturation antigen (BCMA)×cluster of differentiation (CD) 3 bispecific antibody that binds to both BCMA and CD3 to direct T cells against malignant B cells. Linvoseltamab is being developed by Regeneron Pharmaceuticals, Inc. for multiple indications including multiple myeloma and received its first approval on 28 Apr 2025 in the EU. This article summarises the milestones in the development of linvoseltamab leading to this first approval in the EU as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥ 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
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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