ENHERTU receives approval for HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer
Posted on February 3, 2025
AstraZeneca and Daiichi Sankyo’s ENHERTU receive approval for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer, as determined by a Food and Drug Administration -approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
Aditya Bardia, MD, MPH, Program Director of Breast Oncology and Director of Translational Research Integration, UCLA Health Jonsson Comprehensive Cancer Center, US, and investigator in the DESTINY-Breast06 trial, said: “Endocrine therapy is typically used in the initial treatment of HR-positive metastatic breast cancer and following progression, subsequent chemotherapy is associated with poor outcomes. With a median progression-free survival exceeding one year and a response rate of more than 60 percent, trastuzumab deruxtecan offers a potential new standard of care for patients with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer following endocrine therapy.”
Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca, said: “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. The approval also highlights the importance of testing metastatic breast cancer tumors for detectable staining with a standard IHC test to identify those who may be eligible for treatment with ENHERTU following endocrine therapy.”
Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, said: “ENHERTU continues to redefine the classification and treatment of HR-positive metastatic breast cancer with important new data across the spectrum of HER2 expression. Today’s approval underscores our ongoing commitment to realizing the full potential of this innovative antibody drug conjugate and represents another paradigm shift in how certain breast cancers can be treated.”
Krissa Smith, Vice President, Education, Susan G. Komen, said: “We are excited to see more treatment options for these patients which enable more personalized care. It is critical for patients to understand the HER2 status of their metastatic breast cancer to help them make informed treatment decisions. Patients with tumors that are HER2-low or HER2-ultralow now have more options to consider with their healthcare team.”
Related Topics and Keywords
enhertu, ER2-directed therapy, HER2, HER2+ Metastatic Breast Cancer, metastatic breast cancer
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