By Fineline Cube 
Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (NASDAQ: AZN) announced that their co-developed Trop-2-directed antibody and topoisomerase inhibitor conjugate, Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), has received marketing approval in the European Union (EU). The drug is indicated for adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
Drug Mechanism
Datroway is a Trop-2-targeted antibody-drug conjugate (ADC) designed to deliver a topoisomerase inhibitor directly to cancer cells expressing Trop-2. This mechanism allows for precise targeting and enhanced therapeutic effects while minimizing systemic exposure.
Clinical Trial Results
The approval is supported by positive results from the TROPION-Breast01 study, which demonstrated significant improvements in key endpoints:
- Median Progression-Free Survival (mPFS): 6.9 months for Datroway vs. 4.9 months for chemotherapy.
- Objective Response Rate (ORR): 36% for Datroway vs. 23% for chemotherapy.
- Median Duration of Response (mDOR): 6.7 months for Datroway vs. 5.7 months for chemotherapy.
Global Approval Timeline
This EU approval follows similar regulatory clearances in Japan (December 2024) and the US (January 2025), underscoring the global recognition of Datroway’s efficacy and safety profile in treating HR+/HER2- breast cancer.-Fineline Info & Tech