AstraZeneca: FDA extends approval of Enhertu
(CercleFinance.com) - AstraZeneca announced on Tuesday that the US FDA has approved its Enhertu antibody-drug conjugate for a new indication in breast cancer.
The biopharmaceutical group explains that the FDA's green light concerns the treatment of patients with metastatic breast cancer with low or very low HER2 expression whose disease has progressed despite the administration of at least one endocrine therapy.
In a Phase III trial, Enhertu was shown to reduce the risk of disease progression or death in this indication by 36% compared to chemotherapy.
Median progression-free survival reached 13.2 months in the Enhertu group, compared with 8.1 months in subjects receiving chemotherapy.
Enhertu - an antibody-drug conjugate specifically designed to target HER2 marketed with Japan's Daiichi Sankyo - was previously approved for inoperable or metastatic HER2-positive breast cancer.
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The biopharmaceutical group explains that the FDA's green light concerns the treatment of patients with metastatic breast cancer with low or very low HER2 expression whose disease has progressed despite the administration of at least one endocrine therapy.
In a Phase III trial, Enhertu was shown to reduce the risk of disease progression or death in this indication by 36% compared to chemotherapy.
Median progression-free survival reached 13.2 months in the Enhertu group, compared with 8.1 months in subjects receiving chemotherapy.
Enhertu - an antibody-drug conjugate specifically designed to target HER2 marketed with Japan's Daiichi Sankyo - was previously approved for inoperable or metastatic HER2-positive breast cancer.
Copyright (c) 2025 CercleFinance.com. All rights reserved.