Drug updated on 1/31/2025
| Dosage Form | Injection (intravenous; 100 mg lyophilized powder in a single-dose vial) |
| Drug Class | Trop-2-directed antibodies and topoisomerase inhibitor conjugates |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (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
Latest News
Summary
- This summary is based on the review of one systematic review/meta-analysis. [1]
- In HR+/HER2-low MBC, T-DXd and SG showed no significant difference in PFS or OS, though P-score analysis favored T-DXd for PFS (0.90 vs. 0.60) and OS (0.89 vs. 0.60); both significantly outperformed standard chemotherapy in PFS and OS (all p < 0.001), with Dato-DXd demonstrating the worst performance and T-DXd noted as the only ADC significantly outperforming chemotherapy in OS.
- In TN/HER2-low MBC, T-DXd and SG showed no significant difference in PFS or OS, though P-score analysis favored SG for OS (0.80 vs. 0.69); both significantly outperformed standard chemotherapy in PFS and OS (all p < 0.001).
- In HR+/HER2-low and TN/HER2-low MBC, SG showed higher rates of neutropenia, diarrhea, and alopecia.
- T-DXd exhibited higher rates of thrombocytopenia, fatigue, and nausea, was associated with pneumonitis and cardiotoxicity, and had more toxicity-related discontinuations compared to SG.
- In chemotherapy-pretreated patients, both ADCs improved PFS and OS with safety profiles consistent across these subgroups.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Datroway (datopotamab deruxtecan-dlnk) Prescribing Information. | 2025 | Daiichi Sankyo, Inc., Basking Ridge, NJ 07920 AstraZeneca Pharmaceuticals LP, Wilmington, DE |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of antibody-drug conjugates in pretreated HER2-low metastatic breast cancer: A systematic review and network meta-analysis | 2025 | Cancer Treatment Reviews |