Targeted Therapy / Oncology

Enhertu (fam-trastuzumab deruxtecan-nxki)

AstraZeneca / Daiichi Sankyo · HER2-Targeted ADC — Topoisomerase I Inhibitor Payload

FDA Approved 2019 Intravenous (IV) infusion Specialty Medication
Enhertu fam-trastuzumab deruxtecan vials, AstraZeneca Daiichi Sankyo

What is Enhertu? Enhertu (fam-trastuzumab deruxtecan-nxki, T-DXd) is a HER2-targeted ADC by AstraZeneca/Daiichi Sankyo that has transformed treatment for HER2-positive, HER2-low, and HER2-ultralow breast cancer, HER2-positive gastric cancer, and HER2-mutant NSCLC.

About Enhertu

Brand NameEnhertu
Generic / INNfam-trastuzumab deruxtecan-nxki
Drug ClassHER2-Targeted ADC — Topoisomerase I Inhibitor Payload
ManufacturerAstraZeneca / Daiichi Sankyo
AdministrationIntravenous (IV) infusion
FDA Approval2019
📦 100 mg/vial lyophilized powder. Different from Kadcyla — different payload, dosing, and indications.

FDA-Approved Uses

  • HER2-positive metastatic breast cancer — after prior trastuzumab
  • HER2-low metastatic breast cancer (IHC 1+ or IHC 2+/ISH-)
  • HER2-ultralow metastatic breast cancer — HR+
  • HER2-positive gastric/GEJ adenocarcinoma — after prior trastuzumab
  • HER2-mutant NSCLC — after prior platinum-based chemotherapy
Biomarker Note: HER2 testing required across spectrum: HER2+ (IHC 3+), HER2-low (IHC 1+ or 2+/ISH-), HER2-ultralow. HER2 mutation NGS testing required for NSCLC indication.

How Does Enhertu Work?

Enhertu delivers DXd (topoisomerase I inhibitor) into HER2-expressing cells. After internalization, DXd causes DNA damage and apoptosis. Its 'bystander effect' kills adjacent tumor cells even with low/no HER2 expression — explaining activity in HER2-low disease.

Dosage & Administration

5.4 mg/kg IV every 3 weeks (breast/NSCLC); 6.4 mg/kg (gastric). First infusion 90 minutes; if tolerated 30–60 minutes subsequently. NOT interchangeable with Kadcyla (T-DM1).

⚠️ Important

Dosing is individualized by the treating oncologist. Do not adjust without medical guidance. This page is educational only.

Warnings & Side Effects

BOXED WARNING: ILD/pneumonitis — can be fatal. Monitor at every visit. Embryo-fetal toxicity. Neutropenia. Left ventricular dysfunction.

⛔ Serious Warnings
  • ILD/pneumonitis — BOXED WARNING, can be fatal
  • Left ventricular dysfunction
  • Neutropenia
  • NOT interchangeable with Kadcyla (T-DM1)
  • Embryo-fetal toxicity

Common Side Effects

  • Nausea
  • Fatigue
  • Alopecia
  • Vomiting
  • Constipation
  • Decreased appetite
  • Anemia
  • Neutropenia

Storage & Handling

Refrigerate at 2°C to 8°C (36°F to 46°F). Do not freeze.

💰 Medication Cost & Insurance Coverage

Approximate Wholesale Acquisition Cost (WAC / List Price)

~$18,000–$22,000/month

5.4 mg/kg every 3 weeks

Coverage note: Medicare Part B; AstraZeneca/Daiichi support
⚠️ List Price vs. What You Pay

WAC is the manufacturer list price — not what most patients pay. Actual cost depends on insurance, deductible, copay tier, and patient assistance eligibility. Many patients pay $0–$100/month through manufacturer co-pay programs.

Patient Assistance Prior Authorization Insurance & Savings

Insurance & Prior Authorization

Enhertu requires prior authorization from all major insurance plans. BiologicHealthPlus handles the full PA process — clinical documentation, peer-to-peer reviews, and appeals — at no cost to patients or providers.

Prior Authorization Guide Patient Assistance Insurance & Savings

Frequently Asked Questions — Enhertu

Enhertu is a HER2-targeted ADC delivering a topoisomerase I inhibitor into HER2-expressing cells. It has transformed treatment for HER2-positive AND HER2-low breast cancer.

HER2-low (IHC 1+ or 2+/ISH-) was previously considered HER2-negative. Enhertu is the first approved therapy for HER2-low metastatic breast cancer — representing ~50-60% of all breast cancers.

No — different payload, different dosing, different indications. NOT interchangeable.

ILD/pneumonitis can be fatal. Grade 1 requires dose interruption; Grade 2+ may require permanent discontinuation. Report any new breathing symptoms immediately.

Related Medications

Kadcyla (different drug)  ·  Herceptin (trastuzumab)  ·  Perjeta  ·  Keytruda

Related Conditions

HER2-positive breast cancer  ·  HER2-low breast cancer  ·  HER2-positive gastric cancer  ·  HER2-mutant NSCLC

Medical Disclaimer: Educational purposes only. Not medical advice. Consult your oncologist for treatment decisions. Prices are approximate WAC list prices as of 2025-2026. Last reviewed: September 2026 — BiologicHealthPlus Clinical Team.