# Hepatocellular carcinoma

The EU has approved 11 indications of 10 drugs in hepatocellular carcinoma. 1 of them needs a biomarker result: AFP (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### AFP

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Ramucirumab](https://oncolabels.com/drugs/ramucirumab) (Cyramza) | Serum AFP ≥ 400 ng/ml | Monotherapy | 2nd line, advanced | After sorafenib |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | None | + bevacizumab | 1st line, advanced | No prior systemic therapy |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | None | + tremelimumab | 1st line, advanced | - |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | None | Monotherapy | 1st line, advanced | - |
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | None | + nivolumab | 1st line, advanced | - |
| [Lenvatinib](https://oncolabels.com/drugs/lenvatinib) (Lenvima) | None | Monotherapy | 1st line, advanced | - |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | + ipilimumab | 1st line, advanced | - |
| [Tremelimumab](https://oncolabels.com/drugs/tremelimumab) (Imjudo) | None | + durvalumab | 1st line, advanced | - |
| [Cabozantinib](https://oncolabels.com/drugs/cabozantinib) (Cabometyx) | None | Monotherapy | 2nd line | Previously been treated with sorafenib |
| [Regorafenib](https://oncolabels.com/drugs/regorafenib) (Stivarga) | None | Monotherapy | 2nd line | Previously treated with sorafenib |
| [Sorafenib](https://oncolabels.com/drugs/sorafenib) (Nexavar) | None | Monotherapy | Any line | - |

## 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

- **Nivolumab** (Opdivo), Hepatocellular carcinoma, 1st line, advanced: “OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Cabozantinib** (Cabometyx), Hepatocellular carcinoma, 2nd line: “CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Hepatocellular carcinoma, 1st line, advanced: “IMFINZI as monotherapy is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Hepatocellular carcinoma, 1st line, advanced: “IMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Hepatocellular carcinoma, 1st line, advanced: “Tecentriq, in combination with bevacizumab, is indicated for the treatment of adult patients with advanced or unresectable HCC who have not received prior systemic therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Hepatocellular carcinoma, 1st line, advanced: “YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Sorafenib** (Nexavar), Hepatocellular carcinoma, any line: “Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nexavar-epar-product-information_en.pdf)
- **Lenvatinib** (Lenvima), Hepatocellular carcinoma, 1st line, advanced: “LENVIMA as monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lenvima-epar-product-information_en.pdf)
- **Regorafenib** (Stivarga), Hepatocellular carcinoma, 2nd line: “- hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf)
- **Tremelimumab** (Imjudo), Hepatocellular carcinoma, 1st line, advanced: “IMJUDO in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imjudo-epar-product-information_en.pdf)
- **Ramucirumab** (Cyramza), Hepatocellular carcinoma, 2nd line, advanced: “Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.” [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/hepatocellular-carcinoma