# Solid tumours, tumour-agnostic

The EU has approved 6 indications of 6 drugs in solid tumours, tumour-agnostic. Each needs a biomarker result: NTRK (3), EpCAM (1), HER2 (1) and RET (1).

## Approved indications

### 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

- **Entrectinib** (Rozlytrek), Solid tumours, tumour-agnostic, any line: “Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients older than 1 month with solid tumours that have a NTRK gene fusion,  who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and  who have not received a prior NTRK inhibitor  who have no satisfactory treatment options (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rozlytrek-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)
- **Larotrectinib** (Vitrakvi), Solid tumours, tumour-agnostic, any line: “VITRAKVI as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion,
- who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and
- who have no satisfactory treatment options (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/vitrakvi-epar-product-information_en.pdf)
- **Selpercatinib** (Retsevmo), Solid tumours, tumour-agnostic, advanced: “advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf)
- **Catumaxomab** (Korjuny), Solid tumours, tumour-agnostic, 2nd line: “Korjuny is indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/korjuny-epar-product-information_en.pdf)
- **Repotrectinib** (Augtyro), Solid tumours, tumour-agnostic, advanced: “AUGTYRO as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with advanced solid tumours expressing a NTRK gene fusion, and  who have received a prior NTRK inhibitor, or  have not received a prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/augtyro-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/solid-tumours-tumour-agnostic