# Thyroid cancer

The EU has approved 9 indications of 7 drugs in thyroid cancer. 5 of them need a biomarker result: RET (3) and BRAF (2). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### BRAF mutation

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Dabrafenib](https://oncolabels.com/drugs/dabrafenib) (Tafinlar) | BRAF V600E | + trametinib | 2nd line, advanced | Differentiated thyroid cancer only; After prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) |
| [Trametinib](https://oncolabels.com/drugs/trametinib) (Mekinist) | BRAF V600E | + dabrafenib | 2nd line, advanced | Differentiated thyroid cancer only; Progressed during or after prior systemic therapy; Refractory to or not eligible for radioactive iodine (RAI) |

### RET

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Radioactive iodine-refractory (if radioactive iodine is appropriate); aged 2 years and older |
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET mutation | Monotherapy | Advanced | Medullary thyroid cancer only; Aged 2 years and older |
| [Vandetanib](https://oncolabels.com/drugs/vandetanib) (Caprelsa) | RET mutation | Monotherapy | Advanced | Medullary thyroid cancer only; Aggressive and symptomatic disease; aged 5 years and older |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Cabozantinib](https://oncolabels.com/drugs/cabozantinib) (Cabometyx) | None | Monotherapy | 2nd line, advanced | Differentiated thyroid cancer only; Progressed during or after prior systemic therapy; Refractory or not eligible to radioactive iodine (RAI) |
| [Cabozantinib](https://oncolabels.com/drugs/cabozantinib) (Cometriq) | None | Monotherapy | Advanced | Medullary thyroid cancer only; Progressive disease |
| [Lenvatinib](https://oncolabels.com/drugs/lenvatinib) (Lenvima) | None | Monotherapy | Advanced | Differentiated thyroid cancer only; Refractory to radioactive iodine (RAI); progressive disease |
| [Sorafenib](https://oncolabels.com/drugs/sorafenib) (Nexavar) | None | Monotherapy | Advanced | Differentiated thyroid cancer only; Progressive; refractory to radioactive iodine |

## 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

- **Cabozantinib** (Cabometyx), Thyroid cancer, 2nd line, advanced: “CABOMETYX is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf)
- **Cabozantinib** (Cometriq), Thyroid cancer, advanced: “COMETRIQ is indicated for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cometriq-epar-product-information_en.pdf)
- **Vandetanib** (Caprelsa), Thyroid cancer, advanced: “Caprelsa is indicated for the treatment of aggressive and symptomatic Rearranged during Transfection (RET) mutant medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/caprelsa-epar-product-information_en.pdf)
- **Selpercatinib** (Retsevmo), Thyroid cancer, advanced: “advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf)
- **Selpercatinib** (Retsevmo), Thyroid cancer, advanced: “advanced RET-mutant medullary thyroid cancer (MTC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf)
- **Trametinib** (Mekinist), Thyroid cancer, 2nd line, advanced: “Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf)
- **Dabrafenib** (Tafinlar), Thyroid cancer, 2nd line, advanced: “Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf)
- **Sorafenib** (Nexavar), Thyroid cancer, advanced: “Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nexavar-epar-product-information_en.pdf)
- **Lenvatinib** (Lenvima), Thyroid cancer, advanced: “LENVIMA as monotherapy is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/lenvima-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/thyroid-cancer