{"title":"Sotorasib’s Accelerated Approval","authors":"Mark J. Ratain, Aaron S. Kesselheim","doi":"10.1001/jamaoncol.2025.0039","DOIUrl":null,"url":null,"abstract":"This Viewpoint reviews the accelerated approval process and lack of postapproval studies to verify its benefit as it applied to sotorasib, a treatment for non–small cell lung cancer with the <jats:italic>KRAS</jats:italic><jats:sup>g12c</jats:sup> mutation, and recommends measures to ensure confirmatory follow-up studies.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"213 1","pages":""},"PeriodicalIF":22.5000,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamaoncol.2025.0039","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
This Viewpoint reviews the accelerated approval process and lack of postapproval studies to verify its benefit as it applied to sotorasib, a treatment for non–small cell lung cancer with the KRASg12c mutation, and recommends measures to ensure confirmatory follow-up studies.
期刊介绍：
JAMA Oncology is an international peer-reviewed journal that serves as the leading publication for scientists, clinicians, and trainees working in the field of oncology. It is part of the JAMA Network, a collection of peer-reviewed medical and specialty publications.
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