Enhertu
Enhertu ingredients
| Active ingredient | Strength |
|---|---|
| Trastuzumab Deruxtecan | 100 mg/5mL |
What Enhertu is used for
The FDA lists the approved uses on the official label (below). In the EU, trastuzumab deruxtecan is approved as Enhertu for:
Breast cancerHER2-positive breast cancerEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.HER2-low and HER2-ultralow breast cancerEnhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1). HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2). Non-small cell lung cancer (NSCLC)Enhertu as monotherapy is i…
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Enhertu
- Generic name
- Fam-trastuzumab deruxtecan-nxki
- Made by
- Daiichi Sankyo Inc.
- Forms
- Injection, Powder, Lyophilized, For Solution
- Given
- Intravenous
- FDA approval
- Biologic licence (BLA) BLA761139
- On the US market since
- 2019
Official information
- Enhertu prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Fam-trastuzumab deruxtecan-nxki)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Enhertu?
Enhertu (Fam-trastuzumab deruxtecan-nxki) is a cancer medicine made by Daiichi Sankyo Inc., approved by the US FDA.
What are the ingredients of Enhertu?
Enhertu contains Trastuzumab Deruxtecan (100 mg/5mL).
Is Enhertu approved in Europe?
The same active substance is approved in the EU as Enhertu.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA