The European Commission (EC) has granted approval to Enhertu (trastuzumab deruxtecan), developed jointly by AstraZeneca and Daiichi Sankyo, for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have no satisfactory treatment options remaining.
This approval marks a significant milestone in precision oncology, making Enhertu the first HER2-directed tumour-agnostic therapy and the first antibody-drug conjugate (ADC) approved in the European Union for use across multiple HER2-positive solid tumours based solely on biomarker status rather than the cancer’s site of origin.
What Makes This Approval Historic?
Traditionally, cancer treatments are approved for specific tumour types such as breast, lung, or gastric cancer. However, Enhertu’s new indication follows a tumour-agnostic approach, meaning eligible patients can receive treatment based on the presence of HER2 overexpression (IHC 3+), regardless of where the cancer started.
This represents a major advancement in personalized medicine, where treatment decisions are guided by the molecular characteristics of the tumour instead of its anatomical location.
Clinical Evidence Supporting the Approval
The European Commission based its decision on strong clinical evidence from multiple Phase II studies that demonstrated meaningful and durable responses in patients with HER2-positive cancers.
Key clinical trials include:
- DESTINY-PanTumor02
- DESTINY-Lung01
- DESTINY-CRC02
- HERALD Study
The studies showed encouraging efficacy across a broad range of HER2-expressing advanced solid tumours, particularly in patients who had exhausted standard treatment options.
Cancers Covered Under the New Indication
HER2 overexpression is observed in several advanced cancers, including:
- Biliary Tract Cancer
- Bladder Cancer
- Cervical Cancer
- Endometrial Cancer
- Ovarian Cancer
- Colorectal Cancer
- Lung Cancer
- Other HER2-positive Advanced Solid Tumours
The approval provides a new targeted treatment option for patients with these difficult-to-treat cancers after previous therapies have failed.
About Enhertu
Enhertu (trastuzumab deruxtecan) is a next-generation Antibody-Drug Conjugate (ADC) that combines a HER2-targeting monoclonal antibody with a potent chemotherapy payload. The therapy delivers the cytotoxic drug directly to HER2-expressing cancer cells, helping maximize anti-tumour activity while limiting damage to healthy tissues.
Enhertu has already become one of the most important targeted therapies in oncology and is approved worldwide for multiple HER2-positive cancers.
Expanding Enhertu’s Role in Cancer Treatment
With this latest authorization, Enhertu is now approved in the European Union for six different oncology indications, including:
- HER2-positive Breast Cancer
- Gastric Cancer
- Non-Small Cell Lung Cancer (NSCLC)
- HER2-positive Tumour-Agnostic Solid Tumours
- Additional approved HER2-related indications
The approval further strengthens AstraZeneca’s precision oncology portfolio and demonstrates the increasing importance of biomarker-driven cancer treatment strategies.
Why This Matters
The European Commission’s decision reflects a growing shift toward precision medicine, where patients receive therapies based on the unique genetic and molecular profile of their cancer rather than its location in the body.
For patients with advanced HER2-positive solid tumours who have limited treatment options, Enhertu offers a promising targeted therapy that may improve treatment outcomes and expand access to personalized cancer care across Europe.
Conclusion
The approval of Enhertu as the European Union’s first HER2-targeted tumour-agnostic antibody-drug conjugate represents a landmark achievement in oncology. By enabling treatment based on HER2 biomarker status across multiple cancer types, this decision opens new possibilities for patients with advanced cancers and reinforces the future of precision medicine in cancer treatment.
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