15th Dec 2025 20:46
(Alliance News) - AstraZeneca PLC on Monday said enhertu plus pertuzumab has been approved in the US as a first-line treatment of patients with HER2-positive metastatic breast cancer.
Enhertu is developed through a global collaboration between Tokyo-based pharmaceutical company Daiichi Sankyo Co Ltd, and Cambridge, England-based AstraZeneca, who jointly develop and commercialise it worldwide, except in Japan where Daiichi Sankyo holds exclusive rights.
AstraZeneca said the US Food & Drug Administration approval follows priority review and breakthrough therapy designation by the FDA and is based on the results of the Destiny-Breast09 phase 3 trial.
This showed that enhertu in combination with pertuzumab reduced the risk of disease progression or death by 44% versus trihexyphenidyl, with a median progression-free survival of more than three years.
"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," said Dave Fredrickson, executive vice president, Oncology Haematology Business Unit, AstraZeneca.
Following the approval in the US, AstraZeneca will pay USD150 million to Daiichi Sankyo as a milestone payment.
Shares in AstraZeneca closed up 0.2% at 13,472.00 pence in London on Monday. Daiichi Sankyo rose 3.5% to JPY3,479 in Tokyo on Monday.
By Jeremy Cutler, Alliance News reporter
Comments and questions to [email protected]
Copyright 2025 Alliance News Ltd. All Rights Reserved.
Related Shares:
Astrazeneca