CHMP recommends EU approval of Enhertu for previously treated HER2-positive metastatic Solid tumours

CAR-T Digest - August 2020

Weekly Digest - May 2026

22 May 2026: CHMP recommends EU approval of Enhertu for previously treated HER2-positive metastatic Solid tumours

AstraZeneca and Daiichi Sankyo have received a positive CHMP opinion for Enhertu in previously treated unresectable or metastatic HER2-positive (IHC 3+) solid tumors with no satisfactory treatment options, positioning the HER2-directed ADC for a landmark expansion beyond traditional tumor-specific indications in Europe
The recommendation was supported by data from the Phase 2 DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 studies, where Enhertu demonstrated durable and clinically meaningful responses across HER2-positive tumors with a safety profile consistent with previous studies
If approved by the European Commission, Enhertu would become the first HER2-targeted therapy and the first ADC in the EU to secure a tumor-agnostic indication, representing a significant regulatory precedent and expanding its addressable patient population across multiple rare and difficult-to-treat cancers
Enhertu is a HER2-directed DXd ADC developed by AstraZeneca and Daiichi Sankyo, combining a HER2 monoclonal antibody with a cleavable linker and a topoisomerase I inhibitor payload (DXd), designed to deliver potent antitumor activity along with a bystander killing effect in heterogeneous tumors
Strategically, the CHMP opinion reinforces the accelerating shift toward biomarker-driven, tissue-agnostic treatment paradigms and highlights the increasing role of ADCs in delivering precision oncology solutions across multiple solid tumor settings, potentially setting a benchmark for future tumor-agnostic ADC approvals