Regulatory approval

Published by the Food and Drug Administration. Approved

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

This is written in the approval document.

Citation

Daiichi Sankyo, Inc. Enhertu (trastuzumab deruxtecan) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761139s038s042lbl.pdf. Revised December 2025. Accessed December 24, 2025.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) HER2-positive Any solid tumor Trastuzumab deruxtecan