FDA Approval Expands Earlier Use of Enhertu for Metastatic Breast Cancer

MONDAY, Feb. 3, 2025 (HealthDay News) — The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-low or HER2-ultralow breast cancer.

The approval was granted through Priority Review and Breakthrough Therapy Designation pathways, with HR and HER status determined by an FDA-approved test. Additionally, patients had to have had disease progression after one or more endocrine therapies.

Results from the DESTINY-Breast06 phase 3 trial showed that Enhertu demonstrated superiority compared with chemotherapy. Enhertu showed a significant reduction in the risk for disease progression or death versus chemotherapy (hazard ratio, 0.64) in the overall trial population of patients with chemotherapy-naive HER2-low or HER2-ultralow metastatic breast cancer. Patients randomly assigned to Enhertu had a median progression-free survival of 13.2 months compared with 8.1 months seen for those assigned to chemotherapy. Overall, the confirmed objective response rate was 62.6 percent for Enhertu versus 34.4 percent for chemotherapy.

“Building on the practice-changing previous approvals for Enhertu, this new approval brings this important medicine to an earlier treatment setting and a broader patient population with HER2-expressing metastatic breast cancer,” Dave Fredrickson, executive vice president of the Oncology Haematology Business Unit at AstraZeneca, said in a statement. “The approval also highlights the importance of testing metastatic breast cancer tumors for detectable staining with a standard immunohistochemistry test to identify those who may be eligible for treatment with Enhertu following endocrine therapy.”

Approval of Enhertu was granted to AstraZeneca and Daiichi Sankyo.

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