Enhertu approved in the EU as the first tumor-agnostic HER2-targeted ADC for previously treated HER2 positive metastatic Solid tumors

CAR-T Digest - August 2020

Weekly Digest - July 2026

29 June 2026: Enhertu approved in the EU as the first tumor-agnostic HER2-targeted ADC for previously treated HER2 positive metastatic Solid tumors

The European Union has approved Enhertu as the first tumor-agnostic HER2-directed antibody-drug conjugate for adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) solid tumors with no satisfactory treatment options
The approval is based on results from the phase 2 DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 trials, where Enhertu demonstrated clinically meaningful objective response rates of 52.3%, 52.9%, and 46.9%, respectively, across multiple HER2-positive tumor types
The approval expands treatment options for patients with HER2-positive metastatic solid tumors beyond traditional organ-specific indications, addressing a significant unmet need where HER2-directed therapies were previously unavailable despite HER2 overexpression across multiple cancer types
Enhertu is a HER2-directed DXd antibody-drug conjugate that combines a HER2 monoclonal antibody with a cleavable tetrapeptide linker and a potent topoisomerase I inhibitor payload, enabling targeted cytotoxicity and a bystander killing effect across heterogeneous HER2-expressing tumors
Strategically, the approval establishes a landmark precedent for tumor-agnostic ADCs in Europe, further strengthens Daiichi Sankyo and AstraZeneca’s leadership in HER2-targeted precision oncology, and reinforces the growing role of biomarker-driven ADC therapies in expanding treatment opportunities across multiple solid tumor types