Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Pertuzumab, Trastuzumab deruxtecan in patients with Invasive Breast Carcinoma.
This statement is based on a regulatory approval from the Food and Drug Administration:
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.