TOKYO, June 29, 2026
Daiichi Sankyo and AstraZeneca have announced that the European Commission (EC) has approved Enhertu® (trastuzumab deruxtecan) as the first tumor-agnostic HER2-directed antibody-drug conjugate (ADC) for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have previously received treatment and have no satisfactory therapeutic alternatives. The landmark approval establishes Enhertu as the first HER2-directed therapy and first ADC in the European Union approved regardless of the tumor’s site of origin, significantly expanding precision oncology treatment options for patients with advanced HER2-positive cancers. The decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is supported by positive findings from the Phase 2 DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 clinical trials, demonstrating clinically meaningful and durable responses across multiple HER2-positive solid tumor types. This latest authorization also represents Enhertu’s sixth approved indication in the European Union, further strengthening its position as one of the most significant innovations in targeted oncology treatment.
Phase 2 Clinical Trials Demonstrate Durable Responses Across Multiple Cancers
The European approval is supported by robust efficacy data generated across three multicenter Phase 2 clinical studies evaluating Enhertu in patients with previously treated HER2-positive metastatic cancers. In the DESTINY-PanTumor02 study, the therapy achieved a confirmed objective response rate (ORR) of 52.3% with a median duration of response (DOR) of 21.1 months among patients with HER2-positive biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and other solid tumors. The DESTINY-Lung01 trial demonstrated a 52.9% confirmed ORR in patients with HER2-positive non-small cell lung cancer (NSCLC), while the DESTINY-CRC02 study reported a 46.9% confirmed ORR in patients with previously treated HER2-positive metastatic colorectal cancer.
Across all three studies, the safety profile remained consistent with previous clinical experience, with no new safety signals identified, reinforcing the established benefit-risk profile of Enhertu. These findings further demonstrate the potential of HER2-directed antibody-drug conjugates to deliver clinically meaningful outcomes across a broad spectrum of difficult-to-treat cancers while advancing precision medicine beyond traditional tumor-specific treatment approaches.
Tumor-Agnostic Approval Advances Precision Oncology in Europe
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The approval marks a significant advancement in precision oncology, where treatment decisions are increasingly guided by molecular biomarkers rather than the anatomical origin of cancer. HER2 overexpression occurs across numerous solid tumors and has historically been associated with aggressive disease progression and poor clinical outcomes. Until now, HER2-targeted therapies within the European Union were generally limited to selected cancers such as breast and gastric malignancies. The new tumor-agnostic indication allows physicians to consider Enhertu for eligible patients across multiple HER2-positive tumor types following biomarker testing, expanding access to targeted therapy for individuals with limited treatment options. The approval also reflects the continued success of the global collaboration between Daiichi Sankyo and AstraZeneca, which has transformed Enhertu into one of the world’s leading antibody-drug conjugates through ongoing clinical development across numerous cancer indications.
Enhertu is currently approved in more than 40 countries for this tumor-agnostic indication and continues to demonstrate significant clinical value across breast, gastric, lung, and other HER2-positive cancers. In addition, Daiichi Sankyo will receive a $25 million milestone payment from AstraZeneca following the European approval, reflecting the commercial progress of the collaboration. The European Commission’s decision establishes a new standard for HER2-targeted cancer treatment by expanding access to precision biologic therapy based on tumor biology rather than cancer location, offering renewed hope for patients with advanced metastatic HER2-positive solid tumors while reinforcing the growing role of antibody-drug conjugates in modern oncology.
Source: Daiichi Sankyo, AstraZeneca press release
