Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to trastuzumab deruxtecan in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	HER2-positive	Invasive Breast Carcinoma	Pertuzumab, Trastuzumab deruxtecan	FDA