Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted accelerated approval to trastuzumab deruxtecan as a monotherapy 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. The product label states that this indication is approved under accelerated approval based on objective response rate and duration of response and that 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 as:

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated, as a monotherapy, 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.

Citation

Daiichi Sankyo. Enhertu (fam-trastuzumab deruxtecan-nxki) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761139s041s043lbl.pdf. Revised May 2026. Accessed October 8, 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	HER2-positive	Any solid tumor	Trastuzumab deruxtecan

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-04-05	Food and Drug Administration	Indication received traditional approval.
2022-08-11	Food and Drug Administration	Indication received accelerated approval.