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EMA Accepts Daiichi Sankyo's Application for Enhertu in HER2-Positive Breast Cancer

NEW YORK – Daiichi Sankyo said on Monday that the European Medicines Agency has accepted its marketing authorization application for trastuzumab deruxtecan (Daiichi Sankyo's Enhertu, DS-8201) for previously-treated HER2-positive breast cancer. The application has also been granted accelerated assessment by EMA's Committee for Medicinal Products for Human Use.

The MAA is supported by results from the Phase II DESTINY-Breast01 trial evaluating trastuzumab deruxtecan as a monotherapy for HER2-positive metastatic breast cancer patients who had received previous treatment with trastuzumab emtansine (Genentech's Kadcyla).

In that study, 60 percent of patients saw their tumors shrink, and the median duration of response was 14.8 months. Adverse events were mostly of grade 1 or 2. 

Trastuzumab deruxtecan was granted accelerated approval by the US Food and Drug Administration last year, based on results from the same study, for the treatment of unresectable or metastatic HER2-positive breast cancer that had been previously treated with anti-HER2 regimens.  

In March, Japanese regulators also approved trastuzumab deruxtecan for patients with chemotherapy-treated, unresectable, or recurrent breast cancer.