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AstraZeneca PLC on Friday said its breast cancer therapy, Enhertu, which is being developed jointly with Tokyo-based pharmaceutical company Daiichi Sankyo Co Ltd, has been recommended for approval in the EU. The Cambridge, England-based pharmaceuticals firm said Enhertu, or trastuzumab deruxtecan, has been recommended as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment. The recommendation was made by the Committee for Medicinal Products for Human Use, which is part of the European Medicines Agency, and was based on results from the Destiny-Breast06 phase 3 trial. In the trial, Enhertu demonstrated a 38% reduction in the risk of disease progression or death, in comparison to chemotherapy. ‘Endocrine therapy is typically used in the initial treatment of HR-positive metastatic breast cancer but as the disease progresses the benefit of continued endocrine therapy is limited, and subsequent standard-of-care chemotherapy is associated with poor outcomes,’ said Susan Galbraith, AstraZeneca’s executive vice president, oncology haematology research & development. ‘Enhertu has the potential to be the first HER2-directed treatment for patients in the EU with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer directly following endocrine therapy, which would mark an important shift in how patients in this setting are treated.’ The recommendation follows Enhertu’s recent approval in the US. Regulatory applications for the therapy are also currently under review in Japan and ‘several other countries’. Shares in AstraZeneca were down 0.2% at 11,992.00 pence in London on Friday afternoon. Daiichi Sankyo shares closed down 1.3% at JP¥3,447.00 in Tokyo. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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