Fam-trastuzumab deruxtecan--nxki

(Enhertu)

Fam-trastuzumab deruxtecan--nxki

Drug updated on 11/14/2023

Dosage FormInjection (intravenous: 100 mg/vial)
Drug ClassMultiple
Ongoing and Completed StudiesClinicalTrials.gov

Indication

  • For the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy
  • For the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-approved test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
  • For the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDAapproved test, and who have received a prior systemic therapy
  • For the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumabbased regimen

Product Monograph / Prescribing Information

Document TitleYearSource
Enhertu (fam-trastuzumab deruxtecan-nxki) Prescribing Information.2022Daiichi Sankyo, Inc., Basking Ridge, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Safety of trastuzumab deruxtecan: a meta-analysis and pharmacovigilance study.2022Journal of Clinical Pharmacy and Therapeutics
A review of fam-trastuzumab deruxtecan-nxki in HER2-positive breast cancer. 2021Annals of Pharmacotherapy

Clinical Practice Guidelines

Document TitleYearSource
ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer.2021Annals of Oncology
Breast cancer. Version 3. 2020.2020National Comprehensive Cancer Network
Treating Breast Cancer.2020American Cancer Society