fam-trastuzumab deruxtecan-nxki for injection
for intravenous use Initial U.S. Approval: 2019

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:Metastatic Breast Cancer and Locally Advanced or Metastatic Gastric Cancer. In August, the FDA approved Enhertu (fam-trastuzumab-deruxtecan-nxki) for patients with unresectable or metastatic HER2-low breast cancer, establishing a new disease classification for breast cancer — HER2 low — and offering a new targeted agent for this patient population.

Facts about fam-trastuzumab deruxtecan-nxki

Approval Date:2019
Proprietary Name: On Request
Active Ingredient(s): fam-trastuzumab deruxtecan-nxki
Dosage Forms And Strengths: For injection: 100 mg lyophilized powder in a single-dose via
Manufacturer:
Medicine Approved By: – European Medical Agency (EMA), Food and Drug Administration (FDA), Health Canada, Therapeutic Goods Administration (TGA), Medsafe (NZ)
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)

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