Herceptin
A targeted antibody for HER2-positive breast and stomach cancers.
Where Trastuzumab is approved
All regulators →Of the three regulators tracked here, the first to approve Trastuzumab was the US, on 25 Sep 1998. It is approved in 3 of the 3 regulators tracked here.
- 6 FDA-approved biosimilars: Hercessi, Herzuma, Kanjinti, Ogivri and others
- 2 EU safety letters (DHPC), latest: quality defect for RoActemra / Hemlibra / Herceptin / Kadcyla / MabThera / Phesgo / Tecentriq, 17 Aug 2023
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Trastuzumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Trastuzumab works
All drug targets →- Receptor protein-tyrosine kinase erbB-2 inhibitor InhibitorTarget: ERBB2 erb-b2 receptor tyrosine kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Biliary tract cancerPhase 3
- CholangiocarcinomaPhase 3
- Colon carcinomaPhase 3
- Colorectal cancerPhase 3
- Ductal breast carcinoma in situPhase 3
- Endometrial cancerPhase 3
- Esophageal adenocarcinomaPhase 3
- Esophageal cancerPhase 3
- Gallbladder cancerPhase 3
- Gastroesophageal junction adenocarcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201585, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 5082, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Trastuzumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 4 technology appraisals of Trastuzumab. 4 are current, and 3 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Lapatinib or trastuzumab in combination with an aromatase inhibitor for the first-line treatment of metastatic hormone receptor-positive breast cancer that overexpresses HER2 NICE TA257 | Not recommended | 27 Jun 2012 | Current |
| Trastuzumab for the treatment of HER2-positive metastatic gastric cancer NICE TA208 | Optimised | 24 Nov 2010 | Current |
| Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer NICE TA107 | Recommended | 23 Aug 2006 | Current |
| Guidance on the use of trastuzumab for the treatment of advanced breast cancer NICE TA34 | Recommended | 15 Mar 2002 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Trastuzumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 17 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Trastuzumab
- ATC code
- L01XC03
- ChEMBL
- CHEMBL1201585
- DrugBank
- DB00072
- CAS number
- 180288-69-1
- FDA UNII
- P188ANX8CK
- Wikidata
- Q412616
- Wikipedia
- Trastuzumab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Herceptin is used for
Herceptin is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-authorized companion diagnostic for Herceptin ( 1 , 2.2 ). 1.1 Adjuvant Breast Cancer Herceptin is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies (14.1) ] ) breast cancer as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel as part of a treatment regimen with docetaxel and carboplatin as a single agent following multi-modality anthracycline based therapy. Select patients for therapy based on an FDA-authorized companion diagnostic f…
How it works
12.1 Mechanism of Action The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Herceptin has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Herceptin is a mediator of antibody-dependent cellular cytotoxicity (ADCC). In vitro , Herceptin-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 8 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.