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AstraZeneca PLC on Friday said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Datroway for a form of breast cancer. The Cambridge, England-based pharmaceutical company said that its and Tokyo-based Daiichi Sankyo Co Ltd’s antibody drug conjugate was recommended for approval in the EU based on results from a phase 3 trial. The recommendation is as monotherapy for the 1st-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer, TNBC, who are not candidates for PD-1/PD-L1 inhibitor therapy. AstraZeneca said: ‘If approved, Datroway has the potential to be the first TROP2-directed antibody drug conjugate for patients in the EU with a demonstrated overall survival benefit as 1st-line treatment.’ Susan Galbraith, executive vice president, Oncology Haematology research & development, AstraZeneca, said: ‘As one of the hardest cancers to treat, today only 15% of patients with metastatic triple-negative breast cancer survive beyond five years. This positive opinion from the CHMP marks an important step forward in bringing the potential of Datroway to transform outcomes for patients with this type of cancer in the EU.’ John Tsai, global head, R&D, Daiichi Sankyo said: ‘Triple-negative breast cancer remains one of the most aggressive types of breast cancer, with limited treatment options for patients with metastatic disease who are not candidates for immunotherapy and are currently treated with traditional chemotherapy. This positive recommendation by the CHMP underscores the potential for Datroway to replace traditional chemotherapy in this setting and we look forward to working closely with the EMA to bring this new indication to patients in the EU.’ Datroway is already approved in the EU for the treatment of adults with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting. AstraZeneca shares were 0.9% lower at 13,942.00 pence each on Friday afternoon in London. Daiichi shares closed 1.2% lower at JP¥2,535.50 in Tokyo. Copyright 2026 Alliance News Ltd. All Rights Reserved.
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