Enhertu recommended for approval in the EU by CHMP as adjuvant treatment for patients with residual disease after neoadjuvant treatment for HER2-positive early breast cancer
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, 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.”
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