Enhertu Approved in the EU as First Tumor Agnostic HER2-Directed Therapy for Previously Treated HER2-Positive Metastatic Solid Tumors

Enhertu was |36 min|Daiichi Sankyo and AstraZeneca Receive Approval for Enhertu as First Tumor Agnostic HER2 Directed Therapy in the EU|CI| on June 29, 2026, for previously treated HER2-positive (IHC 3+) metastatic solid tumors, becoming the first tumor agnostic HER2-directed therapy and antibody drug conjugate approved in the EU for these patients.

Enhertu was approved based on data from phase 2 trials DESTINY-PanTumor02, DESTINY-CRC02, and DESTINY-Lung01, which showed clinically meaningful responses across a broad range of HER2-positive solid tumors after prior treatment.

Enhertu is an antibody drug conjugate (ADC) consisting of trastuzumab linked to a cytotoxic payload, designed to target HER2-positive cancer cells and is approved in multiple cancers worldwide, including breast, gastric, and lung cancers, as well as for this new tumor agnostic metastatic solid tumor indication.