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Daiichi Sankyo Co Ltd on Thursday said the European Medicines Agency has validated the application for Enhertu to treat patients with a range of tumours. The Tokyo-based pharmaceutical company said the application has been validated for the treatment of adult patients with HER2 positive unresectable or metastatic solid tumours who have received prior treatment and have no satisfactory alternative treatment options. Enhertu, or trastuzumab deruxtecan, is an antibody drug conjugate that Daiichi Sankyo discovered and is being jointly developed and commercialised with Cambridge, England-based pharmaceutical firm AstraZeneca PLC. The validation is a confirmation that the application has been completed, and starts the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The application is based on data from three phase-two trials where it demonstrated ‘clinically meaningful responses across a broad range of tumours’. ‘Enhertu has shown a clinically meaningful benefit across several studies in HER2 positive metastatic solid cancers and this validation by the EMA is an important first step toward bringing this medicine to these patients in the EU,’ said Daiichi Sankyo Global Head of Research & Development Ken Takeshita. ‘We look forward to working with the EMA to potentially secure a tumour agnostic indication for Enhertu in the EU, similar to several other regions of the world where this approval has been received.’ Daiichi Sankyo shares closed down 0.9% at JP¥3,524.00 in Tokyo on Thursday. Shares in AstraZeneca were up 0.1% at 11,920.00 pence in London. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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