TOC
【FDA Approval Alert】Daiichi Sankyo’s Datroway Approved for HR-Positive, HER2-Negative Breast Cancer (January 17, 2025)
On January 17, 2025, the U.S. FDA approved datopotamab deruxtecan-dlnk (Datroway) for adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, 1+, 2+/ISH-) breast cancer after endocrine therapy and 1–2 prior lines of chemotherapy for metastatic disease. Approval was based on TROPION-Breast01 trial (NCT05104866).
Disease Overview: HR-Positive, HER2-Negative Breast Cancer
HR-positive, HER2-negative breast cancer is the most common subtype, and new TROP2-directed ADCs are emerging for patients resistant to endocrine therapy.
Treatment Summary
- Drug Name: datopotamab deruxtecan-dlnk (Datroway)
- Company: Daiichi Sankyo, Inc.
- Approval Date: January 17, 2025
- Indication: HR-positive, HER2-negative metastatic breast cancer (post-endocrine + 1–2 prior chemotherapy regimens)
- Mechanism of Action: TROP2-directed antibody-drug conjugate (ADC)
- Pivotal Trial: TROPION-Breast01 (NCT05104866)
- Key Efficacy:
- Median PFS: 6.9 vs 4.9 months (HR 0.63; p<0.0001)
- Median OS: 18.6 vs 18.3 months (HR 1.01; not significant)
- ORR: 36% vs 23%
- Median DOR: 6.7 vs 5.7 months
Patient-Friendly Summary
Datroway delivers chemotherapy directly into TROP2-expressing breast cancer cells, offering a new treatment option after endocrine resistance.
M&A Information
- Subsidiary: Not applicable (Daiichi Sankyo in-house development, co-developed with AstraZeneca)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (TSE: 4568)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
