Regulatory approval

Published by the Food and Drug Administration. Approved

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated in combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-approved test.

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.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	HER2-positive	Invasive Breast Carcinoma	Pertuzumab, Trastuzumab deruxtecan

Contributions

Date	Contributor	Description
2025-12-24	Van Allen lab	On 2025-12-15, the US FDA granted approval to trastuzumab deruxtecan in combination with pertuzumab for the first-line treatment of HER2+ unresectable or metastatic breast cancer.
2025-12-15	Food and Drug Administration	Indication received traditional approval.