FDA approves Enhertu as neoadjuvant, adjuvant treatment for breast cancer

FDA approves Enhertu as neoadjuvant, adjuvant treatment for breast cancer

The U.S. Food and Drug Administration has approved AstraZeneca's Enhertu (fam-trastuzumab deruxtecan-nxki) for both the neoadjuvant and adjuvant treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer.

AstraZeneca’s Enhertu recommended for EU approval in HER2-positive solid tumours

AstraZeneca plc (LON:AZN) and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment and who have no satisfactory treatment options. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicin…