# HER2

33 EU-approved indications of 11 drugs need a HER2 result, in 6 tumour types, most of them in breast cancer, gastric and GEJ adenocarcinoma and non-small cell lung cancer.

## Approved indications by tumour

### Non-small cell lung cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2 mutation | Monotherapy | 2nd line, advanced | After platinum-based chemotherapy with or without immunotherapy |

### Triple-negative breast cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Datopotamab deruxtecan](https://oncolabels.com/drugs/datopotamab-deruxtecan) (Datroway) | Triple-negative (ER-negative, PR-negative, HER2-negative) | Monotherapy | 1st line, advanced | Not candidates for PD-1/PD-L1 inhibitor therapy |

### Breast cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pertuzumab](https://oncolabels.com/drugs/pertuzumab) (Perjeta) | HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Neoadjuvant | Locally advanced, inflammatory, or early stage; high risk of recurrence |
| [Pertuzumab + trastuzumab](https://oncolabels.com/drugs/pertuzumab-trastuzumab) (Phesgo) | HER2 IHC 3+ or IHC 2+/ISH-positive | + chemotherapy | Neoadjuvant | Locally advanced, inflammatory, or early stage; high risk of recurrence |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + neoadjuvant chemotherapy | Neoadjuvant | Then adjuvant monotherapy after surgery; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
| [Neratinib](https://oncolabels.com/drugs/neratinib) (Nerlynx) | HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive | Monotherapy | Adjuvant, early | After adjuvant trastuzumab-based therapy completed less than one year ago |
| [Pertuzumab](https://oncolabels.com/drugs/pertuzumab) (Perjeta) | HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Adjuvant, early | High risk of recurrence |
| [Pertuzumab + trastuzumab](https://oncolabels.com/drugs/pertuzumab-trastuzumab) (Phesgo) | HER2 IHC 3+ or IHC 2+/ISH-positive | + chemotherapy | Adjuvant, early | High risk of recurrence |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + docetaxel and carboplatin | Adjuvant, early | - |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + paclitaxel or docetaxel | Adjuvant, early | After adjuvant chemotherapy with doxorubicin and cyclophosphamide |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adjuvant, early | Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) Ambiguous in the label (treatment phase): check the SmPC. |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adjuvant | After neoadjuvant Herceptin + chemotherapy and surgical resection; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
| [Trastuzumab emtansine](https://oncolabels.com/drugs/trastuzumab-emtansine) (Kadcyla) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adjuvant, early | After neoadjuvant taxane-based and HER2-targeted therapy; Residual invasive disease, in the breast and/or lymph nodes |
| [Pertuzumab](https://oncolabels.com/drugs/pertuzumab) (Perjeta) | HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and docetaxel | 1st line, advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |
| [Pertuzumab + trastuzumab](https://oncolabels.com/drugs/pertuzumab-trastuzumab) (Phesgo) | HER2 IHC 3+ or IHC 2+/ISH-positive | + docetaxel | 1st line, advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + docetaxel | 1st line, metastatic | - |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + paclitaxel | 1st line, metastatic | Anthracycline is not suitable |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2 IHC 3+ or IHC 2+/ISH-positive | + pertuzumab | 1st line, advanced | - |
| [Lapatinib](https://oncolabels.com/drugs/lapatinib) (Tyverb) | HER2 IHC 3+ or IHC 2+/ISH-positive | + capecitabine | 2nd line, advanced | Progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting |
| [Lapatinib](https://oncolabels.com/drugs/lapatinib) (Tyverb) | HER2 IHC 3+ or IHC 2+/ISH-positive, HR-negative | + trastuzumab | 2nd line, metastatic | Progressed on prior trastuzumab therapy(ies) in combination with chemotherapy |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2nd line, advanced | After one or more prior anti-HER2-based regimens |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | IHC 1+ or IHC 2+/ISH-negative or IHC 0 with membrane staining (faint, incomplete, ≤10% of tumour cells), HER2-low or HER2-ultralow, HR-positive | Monotherapy | 2nd line, advanced | After at least one endocrine therapy in the metastatic setting; Not considered suitable for endocrine therapy as the next line of treatment |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | IHC 1+ or IHC 2+/ISH-negative, HER2-low | Monotherapy | 2nd line, advanced | After prior chemotherapy in the metastatic setting or disease recurrence during or within 6 months of completing adjuvant chemotherapy |
| [Trastuzumab emtansine](https://oncolabels.com/drugs/trastuzumab-emtansine) (Kadcyla) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2nd line, advanced | After prior trastuzumab and a taxane, separately or in combination; and either prior therapy for locally advanced or metastatic disease, or disease recurrence during or within six months of completing adjuvant therapy |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 3rd line+, metastatic | After at least two prior chemotherapy regimens for metastatic disease including an anthracycline and a taxane (unless unsuitable); failed hormonal therapy for hormone receptor-positive disease (unless unsuitable) |
| [Tucatinib](https://oncolabels.com/drugs/tucatinib) (Tukysa) | HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and capecitabine | 3rd line+, advanced | After at least 2 prior anti-HER2 treatment regimens |
| [Lapatinib](https://oncolabels.com/drugs/lapatinib) (Tyverb) | HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive | + an aromatase inhibitor | Metastatic | Postmenopausal women; not currently intended for chemotherapy |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive, HR-positive | + aromatase inhibitor | Metastatic | No prior trastuzumab; Postmenopausal |

### Gastric and GEJ adenocarcinoma

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1st line, advanced | - |
| [Trastuzumab](https://oncolabels.com/drugs/trastuzumab) (Herceptin, Tuznue) | HER2 IHC 3+ or IHC 2+/ISH-positive | + capecitabine or 5-fluorouracil, and cisplatin | 1st line, metastatic | - |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2nd line, advanced | After prior trastuzumab-based regimen |

### Biliary tract cancer

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Zanidatamab](https://oncolabels.com/drugs/zanidatamab) (Ziihera) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After at least one prior line of systemic therapy |

### Solid tumours, tumour-agnostic

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

## Label wording

- **Pembrolizumab** (Keytruda), Gastric and GEJ adenocarcinoma, 1st line, advanced: “KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, 3rd line+, metastatic: “as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, 1st line, metastatic: “in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, 1st line, metastatic: “in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, metastatic: “in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant, early: “following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant, early: “following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant, early: “in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, neoadjuvant: “in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Breast cancer, adjuvant: “in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab** (Herceptin, Tuznue), Gastric and GEJ adenocarcinoma, 1st line, metastatic: “Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 1st line, advanced: “Enhertu in combination with pertuzumab is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 2nd line, advanced: “Enhertu 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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 2nd line, advanced: “• 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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Breast cancer, 2nd line, advanced: “• 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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Non-small cell lung cancer, 2nd line, advanced: “Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Gastric and GEJ adenocarcinoma, 2nd line, advanced: “Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Trastuzumab deruxtecan** (Enhertu), Solid tumours, tumour-agnostic, 2nd line, advanced: “Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options (see sections 4.4 and 5.1; for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/enhertu-epar-product-information_en.pdf)
- **Pertuzumab** (Perjeta), Breast cancer, neoadjuvant: “the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf)
- **Pertuzumab** (Perjeta), Breast cancer, adjuvant, early: “the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf)
- **Pertuzumab** (Perjeta), Breast cancer, 1st line, advanced: “Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf)
- **Datopotamab deruxtecan** (Datroway), Triple-negative breast cancer, 1st line, advanced: “Datroway as monotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/datroway-epar-product-information_en.pdf)
- **Trastuzumab emtansine** (Kadcyla), Breast cancer, adjuvant, early: “Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf)
- **Trastuzumab emtansine** (Kadcyla), Breast cancer, 2nd line, advanced: “Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kadcyla-epar-product-information_en.pdf)
- **Zanidatamab** (Ziihera), Biliary tract cancer, 2nd line, advanced: “Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/ziihera-epar-product-information_en.pdf)
- **Lapatinib** (Tyverb), Breast cancer, 2nd line, advanced: “in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf)
- **Lapatinib** (Tyverb), Breast cancer, 2nd line, metastatic: “in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf)
- **Lapatinib** (Tyverb), Breast cancer, metastatic: “in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tyverb-epar-product-information_en.pdf)
- **Tucatinib** (Tukysa), Breast cancer, 3rd line+, advanced: “TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tukysa-epar-product-information_en.pdf)
- **Pertuzumab + trastuzumab** (Phesgo), Breast cancer, neoadjuvant: “the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf)
- **Pertuzumab + trastuzumab** (Phesgo), Breast cancer, adjuvant, early: “the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf)
- **Pertuzumab + trastuzumab** (Phesgo), Breast cancer, 1st line, advanced: “Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/phesgo-epar-product-information_en.pdf)
- **Neratinib** (Nerlynx), Breast cancer, adjuvant, early: “Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nerlynx-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/biomarkers/her2