AstraZeneca and Daiichi Sankyo’s Enhertu recommended in EU by CHMP in HER2

The company states: “AstraZeneca (AZN) and Daiichi Sankyo’s (DSNKY) Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry 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 Medicines Agency (EMA) based its positive opinion on results from a subgroup of patients with HER2-positive (IHC 3+) tumours across three Phase II trials, DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02, in which Enhertu demonstrated clinically meaningful responses across a broad range of tumours.”