FDA Approval Expands Earlier Use of Enhertu for Metastatic Breast Cancer
By Lori Solomon HealthDay Reporter
MONDAY, Feb. 3, 2025 -- 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.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted February 2025
Read this next
Breast Cancer Incidence Trends Vary by Age
TUESDAY, July 1, 2025 -- Breast cancer incidence trends differ by age, even among older women, particularly by race and ethnicity and stage at diagnosis, according to a study...
Lower Risk of Alzheimer Disease Seen for Breast Cancer Survivors
MONDAY, June 30, 2025 -- Breast cancer survivors have a lower risk of Alzheimer disease (AD) compared with cancer-free controls, according to a study published online June 20 in...
BRCA Mutations Linked to Breast Implant Anaplastic Large Cell Lymphoma
WEDNESDAY, June 25, 2025 -- For women with breast cancer (BC), BRCA mutations are associated with increased risk of developing breast implant–associated anaplastic large...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.