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EMA Committee Recommends Enhertu Approval in Advanced HER2-Positive Breast Cancer

NEW YORK – Daiichi Sankyo and AstraZeneca announced on Friday that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of trastuzumab deruxtecan (Enhertu) as a treatment for patients with unresectable or metastatic HER2-positive breast cancer who have been previously treated with anti-HER2 agents.

CHMP's positive opinion comes in the wake of updated results from the Phase II DESTINY-Breast01 clinical trial presented during the San Antonio Breast Cancer Symposium this week. The trial evaluated the antibody-drug conjugate in patients who had received at least two prior HER2-targeting therapies and was powered to assess objective response rate as a primary endpoint.

In the study, 61 percent of patients responded to the drug, and the median duration of response was 21 months. The median progression-free survival was 19 months. Although overall survival data were not mature, the trial's investigators estimated that 74 percent of patients remained alive at 18 months.

The European Commission will now review CHMP's positive opinion and decide whether to approve trastuzumab deruxtecan in the EU. The drug has already been approved for HER2-positive breast cancer in the US and in Japan.

"The durable responses demonstrated in the DESTINY-Breast01 trial have never been seen before in this patient setting," José Baselga, AstraZeneca's executive VP of oncology R&D, said in a statement. "If approved by the European Commission, physicians in Europe will have an important new treatment option for patients with previously treated HER2-positive metastatic breast cancer."