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Enhertu approved in US for 1L HER2+ metastatic BC
AstraZeneca and Daiichi Sankyo's Enhertu, in combination with pertuzumab, has received US FDA approval for the first-line treatment of HER2-positive metastatic breast cancer, marking the first new treatment in this category in a decade. The approval is based on the DESTINY-Breast09 trial, which demonstrated a 44% reduction in the risk of disease progression or death, with a median progression-free survival exceeding three years compared to the standard THP regimen. This approval triggers a $150 million milestone payment from AstraZeneca to Daiichi Sankyo. Disclaimer*
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n16 December 2025\n \nEnhertu plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer\n \nBased on DESTINY-Breast09 Phase III trial results that showed AstraZeneca and Daiichi Sankyo's Enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% vs. THP with a median progression-free survival of more than three years\n \nAstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the US for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test.\n \nThe approval follows Priority Review and Breakthrough Therapy Designation by the FDA and is based on the results of the DESTINY-Breast09 Phase III trial. The data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.1\n \nSara Tolaney, MD, MPH, Chief of the Division of Breast Oncology, Dana-Farber Cancer Institute and principal investigator for the trial, said: \"Trastuzumab deruxtecan plus pertuzumab is the only 1st-line treatment approved in more than a decade to demonstrate a statistically significant improvement in progression-free survival over the current standard regimen for patients with HER2-positive metastatic breast cancer. With a median progression-free survival exceeding three years, versus approximately two years with THP, trastuzumab deruxtecan combined with pertuzumab should become a new 1st-line standard of care in this setting.\"\n \nDave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: \"With this approval, we are bringing Enhertu to the earliest setting for HER2-positive metastatic breast cancer, where optimising efficacy has an important impact on long‑term outcomes. The treatment approach with Enhertu plus pertuzumab in DESTINY-Breast09 sets a new benchmark of more than three years without disease progression or death for patients in this setting.\"\n \nKen Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, said: \"Since its initial approval six years ago, Enhert...