FDA grants accelerated approval to datopotamab deruxtecan-dlnk On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.).

FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer.

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#FDAApproval #AcceleratedApproval #OncologyNews
#LungCancerTreatment #CancerResearch

Public Comment of National Center for Health Research Regarding Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway - National Center for Health Research March 10, 2025: National Center for Health Research supports FDA's decision to require that a confirmatory trial is "underway" before granting accelerated approval, but the definition of underway need...

NCHR urges the FDA to strengthen its draft guidance on accelerated approval confirmatory trials, using concrete metrics of when a confirmatory trial is "underway." #FDA #drugtrials #acceleratedapproval #MedSky
Read more: www.center4research.org/nchr-fda-con...

Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval This study aims to determine whether cancer drugs granted accelerated approval from the US Food and Drug Administration ultimately demonstrate clinical

The limitations of #AcceleratedApproval: "...of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did not improve overall survival or quality of life in confirmatory trials after more than 5 years of follow-up..." #drug #Cancer 🧪 #MedSky