AstraZeneca announces EMA validation for Enhertu marketing authorization

The European Medicines Agency has validated the Type II Variation marketing authorization application for Enhertu for the treatment of adult patients with HER2 positive unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. The application is based on data from three phase 2 trials including DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors.