【FDA Approval Alert】Daiichi Sankyo’s Enhertu Approved for HER2-Low and Ultralow Breast Cancer (January 27, 2025)
On January 27, 2025, the U.S. FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer that has progressed following endocrine therapy. The Ventana PATHWAY anti-HER2 (4B5) assay was also approved as a companion diagnostic. Approval was based on the DESTINY-Breast06 trial (NCT04494425).
Disease Overview: HER2-Low and Ultralow Breast Cancer
HER2-low/ultralow breast cancer represents a newly emerging subgroup within traditionally HER2-negative breast cancer, now responsive to HER2-directed ADC therapy after endocrine resistance.
Treatment Summary
- Drug Name: fam-trastuzumab deruxtecan-nxki (Enhertu)
- Company: Daiichi Sankyo, Inc.
- Approval Date: January 27, 2025
- Indication: HR-positive, HER2-low/ultralow breast cancer after endocrine therapy
- Mechanism of Action: HER2-directed antibody-drug conjugate (ADC)
- Pivotal Trial: DESTINY-Breast06 (NCT04494425)
- Key Efficacy:
- HER2-low: Median PFS 13.2 vs 8.1 months (HR 0.62; p<0.0001)
- HER2-ultralow (exploratory): Median PFS 15.1 vs 8.3 months (HR 0.76)
- ORR (measurable disease): 65.7% vs 30.8%
Patient-Friendly Summary
Enhertu delivers chemotherapy directly into HER2-low/ultralow breast cancer cells, offering a new targeted treatment for patients with previously limited options.
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.
