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
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
jamanetwork.com
April 11, 2024 at 5:24 PM
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
FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer.
Learn more ➡️ bit.ly/44fIz4B
#FDAApproval #AcceleratedApproval #OncologyNews
#LungCancerTreatment #CancerResearch
Learn more ➡️ bit.ly/44fIz4B
#FDAApproval #AcceleratedApproval #OncologyNews
#LungCancerTreatment #CancerResearch
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.).
bit.ly
June 26, 2025 at 9:25 PM
FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer.
Learn more ➡️ bit.ly/44fIz4B
#FDAApproval #AcceleratedApproval #OncologyNews
#LungCancerTreatment #CancerResearch
Learn more ➡️ bit.ly/44fIz4B
#FDAApproval #AcceleratedApproval #OncologyNews
#LungCancerTreatment #CancerResearch
"False hope" is a bold take for a drug with a 90% real world continuation rate and a confirmatory study fully enrolled since 2023. C'mon. Let the data answer the clinical benefit question before the headlines write the verdict #RareDisease #DMD #AcceleratedApproval #LetTheScienceLead
September 17, 2026 at 6:48 PM
"False hope" is a bold take for a drug with a 90% real world continuation rate and a confirmatory study fully enrolled since 2023. C'mon. Let the data answer the clinical benefit question before the headlines write the verdict #RareDisease #DMD #AcceleratedApproval #LetTheScienceLead
The #FDA's #acceleratedapproval pathway has delivered some important new medicines to #patients more quickly, but it is plagued by inconsistencies and a lack of #transparency.
buff.ly/czOHY9W
buff.ly/czOHY9W
April 16, 2026 at 3:30 PM
The #FDA's #acceleratedapproval pathway has delivered some important new medicines to #patients more quickly, but it is plagued by inconsistencies and a lack of #transparency.
buff.ly/czOHY9W
buff.ly/czOHY9W
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...
Read more: www.center4research.org/nchr-fda-con...
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...
www.center4research.org
March 11, 2025 at 8:00 PM
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...
Read more: www.center4research.org/nchr-fda-con...