# Cabozantinib

Cabozantinib (Cabometyx, Cometriq, Ipsen Pharma) has 7 EU-approved indications in 4 tumour types.

## Approved indications

### Neuroendocrine tumours

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | Progressed following at least one prior systemic therapy other than somatostatin analogues |

### Hepatocellular carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | Previously been treated with sorafenib |

### Renal cell carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + nivolumab | 1st line, advanced | - |
| None | Monotherapy | 1st line, advanced | Intermediate or poor risk |
| None | Monotherapy | 2nd line, advanced | After prior vascular endothelial growth factor (VEGF)-targeted therapy |

### Thyroid cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line, advanced | Differentiated thyroid cancer only; Progressed during or after prior systemic therapy; Refractory or not eligible to radioactive iodine (RAI) |
| None | Monotherapy | Advanced | Medullary thyroid cancer only; Progressive disease |

## Products

### Cabometyx

- Company: Ipsen Pharma
- Target: Multikinase inhibitor (MET, VEGFR, AXL, RET)
- Class: Other protein kinase inhibitors
- ATC: L01EX07
- EU approval: 9 Sep 2016
- Label revised: 15 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/cabometyx-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/cabometyx

Mechanism (SmPC section 5.1): Small-molecule inhibitor of multiple receptor tyrosine kinases, chiefly MET and VEGF receptors, plus AXL, RET, ROS1 and others, blocking tumour growth, angiogenesis and metastatic progression.

### Cometriq

- Company: Ipsen Pharma
- Target: Multikinase inhibitor (MET, VEGFR, RET)
- Class: Other protein kinase inhibitors
- ATC: L01EX07
- EU approval: 21 Mar 2014
- Label revised: 13 Oct 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/cometriq-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/cometriq-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/cometriq

Mechanism (SmPC section 5.1): Small molecule that inhibits multiple receptor tyrosine kinases, primarily MET and VEGF receptors, as well as RET, AXL, KIT, and FLT3.

## Label wording

- **Cabozantinib** (Cabometyx), Renal cell carcinoma, 1st line, advanced: “CABOMETYX is indicated as monotherapy for advanced renal cell carcinoma
- as first-line treatment of adult patients with intermediate or poor risk (see section 5.1),” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf)
- **Cabozantinib** (Cabometyx), Renal cell carcinoma, 2nd line, advanced: “CABOMETYX is indicated as monotherapy for advanced renal cell carcinoma
- in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf)
- **Cabozantinib** (Cabometyx), Renal cell carcinoma, 1st line, advanced: “CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cabometyx-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)
- **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** (Cabometyx), Neuroendocrine tumours, 2nd line, advanced: “CABOMETYX is indicated for the treatment of adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumours who have progressed following at least one prior systemic therapy other than somatostatin analogues.” [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)

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/drugs/cabozantinib