# Gastric and GEJ adenocarcinoma

The EU has approved 13 indications of 8 drugs in gastric and GEJ adenocarcinoma. 8 of them need a biomarker result: PD-L1 (4), HER2 (2), CLDN18.2 (1) and MMR/MSI (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### CLDN18.2-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Zolbetuximab](https://oncolabels.com/drugs/zolbetuximab) (Vyloy) | Claudin (CLDN) 18.2 positive, HER2-negative | + fluoropyrimidine- and platinum-containing chemotherapy | 1st line, advanced | - |

### dMMR / MSI-H

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | MMR/MSI deficient | Monotherapy | 2nd line, advanced | Disease progression on or following at least one prior therapy |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [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 |

### PD-L1

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | PD-L1 CPS ≥ 5, HER2-negative | + fluoropyrimidine- and platinum-based combination chemotherapy | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 1, HER2-negative | + fluoropyrimidine and platinum-containing chemotherapy | 1st line, advanced | - |
| [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 | - |
| [Tislelizumab](https://oncolabels.com/drugs/tislelizumab) (Tevimbra) | PD-L1 TAP score ≥ 5%, HER2-negative | + platinum and fluoropyrimidine-based chemotherapy | 1st line, advanced | - |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | None | + FLOT chemotherapy | Neoadjuvant, early | Then adjuvant durvalumab + FLOT chemotherapy, followed by monotherapy after surgery |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | None | + FLOT chemotherapy, followed by monotherapy | Adjuvant, early | After neoadjuvant durvalumab + FLOT chemotherapy and surgical resection |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | Monotherapy | Adjuvant | Gastro-oesophageal junction only; After prior neoadjuvant chemoradiotherapy; Residual pathologic disease |
| [Ramucirumab](https://oncolabels.com/drugs/ramucirumab) (Cyramza) | None | + paclitaxel | 2nd line, advanced | After platinum and fluoropyrimidine chemotherapy |
| [Ramucirumab](https://oncolabels.com/drugs/ramucirumab) (Cyramza) | None | Monotherapy | 2nd line, advanced | After platinum or fluoropyrimidine chemotherapy; For whom treatment in combination with paclitaxel is not appropriate |

## Tumour-agnostic approvals

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

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### 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 |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Pembrolizumab** (Keytruda), Gastric and GEJ adenocarcinoma, 2nd line, advanced: “unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **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)
- **Pembrolizumab** (Keytruda), Gastric and GEJ adenocarcinoma, 1st line, advanced: “KEYTRUDA, in combination with fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Oesophageal cancer, adjuvant: “OPDIVO as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Gastric and GEJ adenocarcinoma, 1st line, advanced: “OPDIVO in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-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)
- **Durvalumab** (Imfinzi), Gastric and GEJ adenocarcinoma, neoadjuvant, early: “IMFINZI in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Gastric and GEJ adenocarcinoma, adjuvant, early: “IMFINZI in combination with FLOT chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of adults with resectable gastric or gastro-oesophageal junction adenocarcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Tislelizumab** (Tevimbra), Gastric and GEJ adenocarcinoma, 1st line, advanced: “Tevimbra, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of adult patients with HER-2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma whose tumours express PD-L1 with a tumour area positivity (TAP) score ≥ 5% (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tevimbra-epar-product-information_en.pdf)
- **Zolbetuximab** (Vyloy), Gastric and GEJ adenocarcinoma, 1st line, advanced: “Vyloy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are Claudin (CLDN) 18.2 positive (see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vyloy-epar-product-information_en.pdf)
- **Ramucirumab** (Cyramza), Gastric and GEJ adenocarcinoma, 2nd line, advanced: “Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cyramza-epar-product-information_en.pdf)
- **Ramucirumab** (Cyramza), Gastric and GEJ adenocarcinoma, 2nd line, advanced: “Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cyramza-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/gastric-and-gej-adenocarcinoma