# HER2 in oesophageal cancer

3 EU-approved indications in oesophageal cancer need a HER2 result: pembrolizumab (1st line, advanced), trastuzumab (1st line, metastatic) and trastuzumab deruxtecan (2nd line, advanced).

## Approved indications

### HER2

| 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 | Gastro-oesophageal junction adenocarcinoma only |
| [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 | Gastro-oesophageal junction adenocarcinoma only |
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2 IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2nd line, advanced | Gastro-oesophageal junction adenocarcinoma only; After prior trastuzumab-based regimen |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### HER2

| 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), 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), 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)

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/tumours/oesophageal-cancer/her2