# Basal cell carcinoma

The EU has approved 4 indications of 3 drugs in basal cell carcinoma. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Cemiplimab](https://oncolabels.com/drugs/cemiplimab) (Libtayo) | None | Monotherapy | 2nd line, advanced | Progressed on or intolerant to a hedgehog pathway inhibitor (HHI) |
| [Sonidegib](https://oncolabels.com/drugs/sonidegib) (Odomzo) | None | Monotherapy | Locally advanced | Not amenable to curative surgery or radiation therapy |
| [Vismodegib](https://oncolabels.com/drugs/vismodegib) (Erivedge) | None | Monotherapy | Metastatic | Symptomatic |
| [Vismodegib](https://oncolabels.com/drugs/vismodegib) (Erivedge) | None | Monotherapy | Locally advanced | Inappropriate for surgery or radiotherapy |

## 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

- **Vismodegib** (Erivedge), Basal cell carcinoma, metastatic: “Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erivedge-epar-product-information_en.pdf)
- **Vismodegib** (Erivedge), Basal cell carcinoma, locally advanced: “Erivedge is indicated for the treatment of adult patients with: symptomatic metastatic basal cell carcinoma locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/erivedge-epar-product-information_en.pdf)
- **Cemiplimab** (Libtayo), Basal cell carcinoma, 2nd line, advanced: “LIBTAYO as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have progressed on or are intolerant to a hedgehog pathway inhibitor (HHI).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/libtayo-epar-product-information_en.pdf)
- **Sonidegib** (Odomzo), Basal cell carcinoma, locally advanced: “Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/odomzo-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/basal-cell-carcinoma