EC approves Enhertu as first tumor-agnostic HER2-directed ADC

29 June 2026

The European Commission has approved UK pharma major AstraZeneca (LSE: AZN) and Japanese drugmaker Daiichi Sankyo’s (TYO: 4568) Enhertu (trastuzumab deruxtecan) as a monotherapy for adults with unresectable or metastatic HER2-positive, immunohistochemistry (IHC) 3+, solid tumors who have received prior treatment and have no satisfactory treatment options.

This approval makes Enhertu the first HER2-directed therapy and antibody-drug conjugate (ADC) to receive a tumor-agnostic indication in the European Union.

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