Cambridge, United Kingdom – May 22, 2026
AstraZeneca and Daiichi Sankyo announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Enhertu® (trastuzumab deruxtecan) for adults with previously treated HER2-positive metastatic solid tumours who have no satisfactory treatment options remaining. If formally approved by the European Commission, Enhertu would become the first HER2-directed therapy and first antibody-drug conjugate (ADC) to receive a tumour-agnostic indication in the European Union, representing a major milestone in precision oncology and targeted cancer medicine.
The positive recommendation was supported by clinical findings from three pivotal Phase II trials — DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 — where Enhertu demonstrated clinically meaningful responses across multiple HER2-positive tumour types, including lung, colorectal, bladder, biliary tract, ovarian, pancreatic, cervical, and endometrial cancers. Oncology experts believe the recommendation highlights the growing importance of biomarker-driven cancer treatment strategies capable of targeting genetic abnormalities across diverse tumour origins rather than focusing solely on tumour location.
Enhertu Demonstrates Strong Responses Across Multiple Tumours
In the Phase II DESTINY-PanTumor02 study, Enhertu achieved a confirmed objective response rate (ORR) of 51.4% among previously treated patients with HER2-positive metastatic solid tumours. Researchers additionally reported a median duration of response of 14.2 months, demonstrating durable anti-tumour activity across several difficult-to-treat cancer types.
The DESTINY-Lung01 trial evaluating HER2-overexpressing non-small cell lung cancer showed a confirmed ORR of 52.9%, while the DESTINY-CRC02 colorectal cancer study reported a confirmed ORR of 46.9% in HER2-positive metastatic colorectal cancer patients previously treated with standard therapies. Investigators stated that the consistent efficacy across multiple tumour types reinforces Enhertu’s potential as a broad precision oncology platform targeting HER2 overexpression.
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Clinical researchers noted that HER2 overexpression is associated with aggressive disease progression and poor prognosis in numerous solid tumour types. However, outside breast and gastric cancers, HER2-targeted therapies remain limited for many patients in Europe. If approved, Enhertu could significantly expand treatment access for patients with advanced HER2-positive cancers who currently have few or no targeted therapeutic options available.
The safety profile observed across the studies remained generally consistent with previous Enhertu clinical trials, with no new safety concerns identified during the analyses. Researchers stated that the therapy’s benefit-risk profile remains favorable within heavily pretreated metastatic cancer populations.
ADC Technology Continues Transforming Precision Oncology
Enhertu is a specifically engineered HER2-directed DXd antibody-drug conjugate, combining a HER2-targeting monoclonal antibody with a potent topoisomerase I inhibitor payload connected through a cleavable linker system. This advanced ADC technology enables targeted delivery of cytotoxic agents directly into cancer cells expressing HER2 while minimizing exposure to healthy tissues.
Industry experts consider antibody-drug conjugates one of the fastest-growing areas in oncology due to their ability to merge biologic targeting precision with highly potent anti-cancer payloads. Enhertu has already transformed treatment approaches across HER2-positive breast cancer, gastric cancer, and HER2-mutant lung cancer settings, with ongoing expansion into additional tumour types and earlier treatment lines worldwide.
Analysts believe tumour-agnostic approvals represent a major evolution in cancer medicine because therapies are increasingly being developed based on molecular biomarkers rather than anatomical tumour classification alone. The recommendation for Enhertu reflects broader shifts toward precision oncology, where genetic testing and biomarker profiling guide individualized treatment decisions across multiple cancer types.
AstraZeneca and Daiichi Sankyo Expand Global Oncology Leadership
The CHMP recommendation further strengthens AstraZeneca and Daiichi Sankyo’s leadership within the global oncology market and expands the clinical reach of their collaborative ADC development platform. Enhertu is already approved in more than 95 countries for multiple HER2-positive breast cancer indications and in over 75 countries for HER2-mutant non-small cell lung cancer treatment.
Both companies continue aggressively expanding Enhertu’s clinical development program through numerous ongoing global studies evaluating the therapy as monotherapy and in combination regimens across multiple tumour types. Researchers believe the broad efficacy profile demonstrated across several HER2-expressing cancers may further accelerate adoption of HER2 testing across additional tumour settings where routine screening is not yet standard clinical practice.
As precision oncology continues reshaping global cancer treatment strategies, Enhertu’s potential tumour-agnostic approval represents another major step toward personalized cancer therapies capable of targeting shared molecular drivers across diverse metastatic solid tumours.
Source: AstraZeneca, Daiichi Sankyo press release
