AstraZeneca and Daiichi Sankyo have achieved a significant regulatory milestone after the European Commission approved Enhertu (trastuzumab deruxtecan) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have no satisfactory treatment options.
The approval makes Enhertu the first HER2-directed tumour-agnostic therapy and the first antibody-drug conjugate (ADC) to receive this type of indication in the European Union. Rather than being limited to a specific cancer type, the decision allows the medicine to be used across multiple HER2-positive solid tumours based on the tumour's biomarker status.
The European Commission's decision is supported by evidence from three Phase II clinical trials, including the DESTINY-PanTumor02 study, which demonstrated clinically meaningful and durable responses across a broad range of HER2-expressing cancers. Additional supporting data came from the DESTINY-Lung01, DESTINY-CRC02, and HERALD studies, reinforcing the medicine's activity in different tumour types.
HER2 overexpression is found in several advanced cancers, including biliary tract, bladder, cervical, endometrial, ovarian, colorectal, lung and other solid tumours. Many patients with these rare or difficult-to-treat cancers have limited treatment options after standard therapies fail. The new approval provides an important targeted treatment alternative for eligible patients across the European Union.
Enhertu is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo and has become one of the leading antibody-drug conjugates in oncology. With this latest approval, the medicine is now authorized in the EU for six different indications spanning breast cancer, gastric cancer, non-small cell lung cancer and HER2-positive solid tumours.
The approval further strengthens AstraZeneca's precision oncology portfolio and reflects the growing role of biomarker-driven therapies in cancer treatment. By focusing on HER2 expression rather than the tumour's site of origin, the decision marks another step toward more personalized cancer care, enabling physicians to treat patients based on the molecular characteristics of their disease.
