18th Sep 2026 14:04
(Alliance News) - AstraZeneca PLC and its partner Daiichi Sankyo Co Ltd on Friday announced that their cancer drug Enhertu has been recommended to be approved in the EU for a form of breast cancer.
AstraZeneca, the Cambridge, England-based pharmaceutical company, and its Tokyo-based peer said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of Enhertu as a monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment.
Susan Galbraith, executive vice president, Oncology Haematology research & development, AstraZeneca said: "This positive CHMP opinion marks a significant step towards bringing Enhertu into early-stage HER2-positive breast cancer in the EU. Enhertu cut the risk of disease recurrence by more than half compared to adjuvant standard of care for patients with residual disease, and if approved could redefine post-surgery care in the EU, keeping patients disease-free for longer and increasing the potential for cure."
Earlier on Friday, AstraZeneca said the US Food & Drug Administration granted a 'priority review' designation for efzimfotase alfa, an investigational enzyme replacement therapy.
The FDA accepted and granted 'priority review' designation to Alexion's biologics licence application for efzimfotase alfa to treat patients aged two years and older with hypophosphatasia, a rare inherited metabolic disease.
AstraZeneca shares were 0.8% higher at 12,526.00 pence each on Friday afternoon in London, while Daiichi Sankyo had closed up 0.7% at JPY2,953.50 in Tokyo.
By Tom Budszus, Alliance News slot editor
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