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AstraZeneca PLC on Monday said the European Commission has approved Enhertu as the first tumour-agnostic HER2-directed therapy and antibody drug conjugate in the EU for previously treated patients with HER2-positive metastatic solid tumours. The Cambridge, England-based pharmaceutical company said the approval, alongside Tokyo-based partner Daiichi Sankyo Co Ltd, covers adults with unresectable or metastatic HER2-positive solid tumours who have received prior treatment and have no satisfactory treatment options. It follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is based on data from the phase II Destiny-PanTumor02, Destiny-Lung01 and Destiny-CRC02 trials. The approval marks the first tumour-agnostic indication in the EU for both a HER2-directed therapy and an antibody drug conjugate, allowing Enhertu to be used across multiple HER2-positive tumour types regardless of where the cancer originated. Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Haematology business unit, said: ‘Precision medicine is reshaping cancer care by helping inform treatment decisions based on the molecular and biological characteristics of a patient’s disease.’ He added: ‘Enhertu is already approved in breast, gastric, and lung cancers, and with this approval, clinicians may now consider Enhertu for patients with HER2-positive status across multiple additional tumour types. This highlights the importance of biomarker testing to identify eligible patients and ensure that those with HER2-positive disease are considered for targeted treatment.’ In the Destiny-PanTumor02 trial, Enhertu achieved a confirmed objective response rate of 52.3% in patients with HER2-positive tumours across a range of cancers, including biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers. The safety profile was consistent with previous clinical trials. Following the EU approval, AstraZeneca will make a $25 million milestone payment to Daiichi Sankyo under the companies’ collaboration agreement. Sales of Enhertu in most EU territories are recognised by Daiichi Sankyo. Shares in AstraZeneca opened 0.2% lower at 14,292.00 pence in London on Monday. Daiichi Sankyo shares closed 3.1% higher at JP¥2,614.00 in Tokyo. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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