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FDA Approves Enhertu for HR-Positive, HER2-Low and HER2-Ultralow Metastatic Breast Cancer

NextEdge Admin

29 Jan 2025

2 min 42 sec

Breast Cancer,antibody-drug conjugate,HER2-low

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received FDA approval for treating adult patients 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. The approval follows Priority Review and Breakthrough Therapy Designation, based on DESTINY-Breast06 Phase III trial results presented at ASCO 2024 and published in The New England Journal of Medicine.

Dr. Aditya Bardia of UCLA Health highlighted Enhertu’s impact, stating that while endocrine therapy is the first-line treatment for HR-positive metastatic breast cancer, chemotherapy after progression often leads to poor outcomes. Enhertu demonstrated a median progression-free survival (PFS) exceeding one year and a response rate above 60%, offering a potential new standard of care.

In DESTINY-Breast06, Enhertu reduced the risk of disease progression or death by 36% compared to chemotherapy (HR 0.64; 95% CI: 0.54-0.76; p<0.0001). The median PFS was 13.2 months with Enhertu versus 8.1 months with chemotherapy, while the objective response rate (ORR) was 62.6% for Enhertu compared to 34.4% for chemotherapy. Patients with HER2-ultralow expression experienced benefits comparable to those with HER2-low expression.

Dave Fredrickson of AstraZeneca emphasized that this approval expands Enhertu’s use to an earlier treatment setting and reinforces the importance of HER2 testing. Ken Keller of Daiichi Sankyo described it as a paradigm shift in HR-positive metastatic breast cancer treatment. Krissa Smith of Susan G. Komen underscored the significance of understanding HER2 status for informed treatment decisions.

Enhertu, a HER2-directed DXd antibody-drug conjugate, is already approved in over 70 countries for HER2-low metastatic breast cancer based on DESTINY-Breast04 data, with regulatory reviews ongoing globally for its new indication.