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Name
Trastuzumab Deruxtecan
Alternate Names
fam-trastuzumab deruxtecan nxki
Enhertu
Abbreviations
None
Category
Biologic therapy (BRM, immunotherapy)
Subcategory
antibody drug-conjugate
monoclonal antibody
NSC Number
None
Primary Site
Breast
Stomach
Lung
Solid tumors
Histology
None
Remarks
January 31, 2025 FDA approved trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by the FDA approved test, that has progressed on one or more endocrine therapies in the metastatic setting.
April 5, 2024 FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
September 9, 2022
FDA approved Enhertu (fam-trastuzumab-deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer. Enhertu is a specifically engineered HER2-directed antibody drug conjugate being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
January 15, 2021 FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.
December 17, 2019 The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
April 5, 2024 FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
September 9, 2022
FDA approved Enhertu (fam-trastuzumab-deruxtecan-nxki) for unresectable or metastatic HER2-low breast cancer. Enhertu is a specifically engineered HER2-directed antibody drug conjugate being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
January 15, 2021 FDA has approved Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.
December 17, 2019 The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki for patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
Coding
This drug should be coded
