Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that HER2-positive status confers therapeutic sensitivity to Trastuzumab deruxtecan in patients with Any solid tumor.

The European Medicines Agency (EMA) has authorized trastuzumab deruxtecan as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options.

This statement is based on a regulatory approval from the European Medicines Agency:

Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options.

Citation

Daiichi Sankyo Europe GmbH. Enhertu (trastuzumab deruxtecan) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf. Revised July 2026. Accessed August 2, 2026.

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2026-06-25	European Medicines Agency	Indication received approval from the European Commission.