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Datopotamab deruxtecan FDA Approval Status

FDA Approved: No
Generic name: datopotamab deruxtecan
Company: AstraZeneca and Daiichi Sankyo
Treatment for: Non-Small Cell Lung Cancer

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate in development for the treatment of non-small cell lung cancer.

Development timeline for datopotamab deruxtecan

DateArticle
Apr  2, 2024Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Metastatic HR-Positive, HER2-Negative Breast Cancer
Feb 19, 2024Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer
Dec 18, 2023Two Phase 3 Trials of Datopotamab Deruxtecan Plus Durvalumab Initiated in Patients Across Two Breast Cancer Subtypes
Oct 23, 2023Datopotamab Deruxtecan Improved Progression-Free Survival vs. Chemotherapy in Patients with Previously Treated Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III Trial
Oct 23, 2023Datopotamab Deruxtecan Significantly Extended Progression-Free Survival vs. Chemotherapy in Patients with HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III Trial
Sep 22, 2023Datopotamab Deruxtecan Demonstrated Statistically Significant and Clinically Meaningful Progression-Free Survival Benefit in Patients with HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III Trial
Sep 10, 2023Datopotamab Deruxtecan Plus Durvalumab Showed Promising Clinical Activity in the First-Line Advanced Non-Small Cell Lung Cancer Setting in TROPION-Lung04 Phase 1b Trial
Jun  5, 2023Datopotamab Deruxtecan Combinations Showed Encouraging Tumour Responses in Patients with Advanced Non-Small Cell Lung Cancer in TROPION-Lung02 Phase Ib Trial
Jan 30, 2023TROPION-Lung07 Phase 3 Trial Initiated to Evaluate Datopotamab Deruxtecan in Combination with Pembrolizumab in Patients with Previously Untreated Metastatic Non-Small Cell Lung Cancer
Dec  9, 2022Datopotamab Deruxtecan Showed Promising Responses as Monotherapy and in Combination with Imfinzi in Patients with Metastatic Triple-Negative Breast Cancer in Two Early Trials
Dec  8, 2022Datopotamab Deruxtecan Showed Encouraging and Durable Efficacy in Patients with Heavily Pretreated HR-Positive, HER2-Low or Negative Metastatic Breast Cancer
Aug  9, 2022Datopotamab Deruxtecan-Based Combinations Show Promising Clinical Activity in Patients with Advanced Non-Small Cell Lung Cancer
Jun 13, 2022TROPION-Breast02 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Previously Untreated Metastatic Triple Negative Breast Cancer
Nov 18, 2021TROPION-Breast01 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
Oct 25, 2021Second Clinical Trial Collaboration Initiated to Evaluate Datopotamab Deruxtecan in Combination with KEYTRUDA® (pembrolizumab) in Patients with Metastatic Non-Small Cell Lung Cancer
Sep 20, 2021Datopotamab Deruxtecan Shows Encouraging Tumor Response in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Genomic Alterations
Sep 19, 2021Datopotamab Deruxtecan Shows Encouraging Tumor Response in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Genomic Alterations
May  8, 2021Datopotamab Deruxtecan Late-Breaking Data at ESMO Breast Shows Promising Preliminary Response and Disease Control in Patients with Metastatic Triple Negative Breast Cancer

Further information

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