Datroway FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 18, 2025.
FDA Approved: Yes (First approved January 17, 2025)
Brand name: Datroway
Generic name: datopotamab deruxtecan-dlnk
Dosage form: Lyophilized Powder for Injection
Company: AstraZeneca and Daiichi Sankyo
Treatment for: Breast Cancer
Datroway (datopotamab deruxtecan-dlnk) is a TROP2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of hormone receptor (HR)-positive, human
epidermal growth factor receptor 2 (HER2)-negative breast cancer.
- Datroway is indicated for the treatment of adult patients with unresectable or metastatic, HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
- Approximately 70% of diagnosed cases of breast cancer in the U.S. are HR-positive, HER2-negative (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-). Endocrine therapies are widely given consecutively in the early lines of treatment for HR-positive metastatic breast cancer. The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes. Datroway provides a treatment option for patients whose disease has progressed after endocrine and initial chemotherapy.
- Datroway is an antibody-drug conjugate (ADC) composed of three components: 1) a humanized anti-TROP2 IgG1 monoclonal antibody (mAb), covalently linked to 2) a cytotoxic topoisomerase I inhibitor, via 3) a tetrapeptide-based cleavable linker. Datroway works by binding to TROP2 (trophoblast cell surface antigen 2) on TROP2 expressing tumors where it undergoes internalization into cancer cells to release the cytotoxic drug, which leads to DNA damage and apoptotic cell death.
- Approval for Datroway was based on results from the TROPION-Breast01 Phase III trial which demonstrated a 37% reduction in the risk of disease progression or death versus chemotherapy.
- Datroway is administered by intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Premedication is recommended for the prevention of infusion reactions and nausea and vomiting.
- Warnings and precautions associated with Datroway include interstitial lung disease (ILD) and pneumonitis, ocular adverse reactions (including dry eye, keratitis, blepharitis and meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision), stomatitis and oral mucositis, and fetal harm.
- Common adverse reactions (≥20%) include stomatitis, nausea, fatigue, alopecia, constipation, dry eye, vomiting, and keratitis. Common laboratory abnormalities include decreased leukocytes, decreased calcium, decreased lymphocytes, decreased hemoglobin, decreased neutrophils, increased ALT, increased AST, and increased alkaline phosphatase.
- Datroway is also being evaluated in other cancers, including non-small cell lung cancer and triple negative breast cancer.
Development timeline for Datroway
| Date | Article |
|---|
| Jan 17, 2025 | Approval FDA Approves Datroway (datopotamab deruxtecan-dlnk) for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer |
| Jan 13, 2025 | Datopotamab Deruxtecan Granted Priority Review in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer |
| Dec 9, 2024 | Datopotamab Deruxtecan Granted Breakthrough Therapy Designation in US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer |
| Nov 12, 2024 | Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer |
| Oct 30, 2024 | Three Phase 3 Trials of Datopotamab Deruxtecan-Based Combinations Initiated in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer |
| Sep 23, 2024 | Datopotamab Deruxtecan Final Overall Survival Results Reported in Patients with Metastatic HR-Positive, HER2-Low or Negative Breast Cancer in TROPION-Breast01 Phase III Trial |
| Sep 9, 2024 | Datopotamab Deruxtecan Showed Median Overall Survival of 14.6 Months in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III Trial |
| Sep 8, 2024 | Novel Computational Pathology-Based TROP2 Biomarker for Datopotamab Deruxtecan Was Predictive of Clinical Outcomes in Patients With Non-Small Cell Lung Cancer in TROPION-Lung01 Phase III Trial |
| May 27, 2024 | Datopotamab Deruxtecan Showed Clinically Meaningful Overall Survival Improvement Versus Chemotherapy in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer in TROPION-Lung01 Phase 3 Trial |
| Apr 2, 2024 | Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Metastatic HR-Positive, HER2-Negative Breast Cancer |
| Feb 19, 2024 | Datopotamab Deruxtecan Biologics License Application Accepted in the US for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer |
| Dec 18, 2023 | Two Phase 3 Trials of Datopotamab Deruxtecan Plus Durvalumab Initiated in Patients Across Two Breast Cancer Subtypes |
| Oct 23, 2023 | Datopotamab 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, 2023 | Datopotamab 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, 2023 | Datopotamab 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, 2023 | Datopotamab 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, 2023 | Datopotamab Deruxtecan Combinations Showed Encouraging Tumour Responses in Patients with Advanced Non-Small Cell Lung Cancer in TROPION-Lung02 Phase Ib Trial |
| Jan 30, 2023 | TROPION-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, 2022 | Datopotamab 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, 2022 | Datopotamab Deruxtecan Showed Encouraging and Durable Efficacy in Patients with Heavily Pretreated HR-Positive, HER2-Low or Negative Metastatic Breast Cancer |
| Aug 9, 2022 | Datopotamab Deruxtecan-Based Combinations Show Promising Clinical Activity in Patients with Advanced Non-Small Cell Lung Cancer |
| Jun 13, 2022 | TROPION-Breast02 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Previously Untreated Metastatic Triple Negative Breast Cancer |
| Nov 18, 2021 | TROPION-Breast01 Phase 3 Trial of Datopotamab Deruxtecan Initiated in Patients with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer |
| Oct 25, 2021 | Second Clinical Trial Collaboration Initiated to Evaluate Datopotamab Deruxtecan in Combination with KEYTRUDA® (pembrolizumab) in Patients with Metastatic Non-Small Cell Lung Cancer |
| Sep 20, 2021 | Datopotamab Deruxtecan Shows Encouraging Tumor Response in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Genomic Alterations |
| Sep 19, 2021 | Datopotamab Deruxtecan Shows Encouraging Tumor Response in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Genomic Alterations |
| May 8, 2021 | Datopotamab 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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