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Cabometyx is a cancer medicine used to treat adults with:
- advanced renal cell carcinoma (a kidney cancer). It is used in patients who have been previously treated with a type of cancer medicine called ‘vascular endothelial growth factor (VEGF) inhibitor’. It is also used in patients who have not had previous treatment and whose cancer is at moderate or high risk of rapidly getting worse.
- hepatocellular carcinoma (a liver cancer). It is used on its own in patients who have already been treated with the cancer medicine sorafenib.
- differentiated thyroid carcinoma (a type of cancer originating from the follicular cells of the thyroid gland). Cabometyx is used after systemic therapy (affecting the whole body) when the cancer has progressed or spread locally or to other parts of the body. It is used when the cancer does not respond to treatment with radioactive iodine or in patients who cannot have radioactive iodine.
Cabometyx contains the active substance cabozantinib.
Cabometyx : EPAR - Medicine overview (PDF/149.19 KB)
First published: 12/10/2016
Last updated: 09/06/2022
Cabometyx : EPAR - Risk-management-plan summary (PDF/137.33 KB)
First published: 09/06/2022
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This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.
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65 Quai Georges Gorse
29/09/2022 Cabometyx - EMEA/H/C/004163 - PSUSA/00010180/202111
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Renal Cell Carcinoma (RCC)
Cabometyx is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC):
- in treatment-naïve adults with intermediate or poor risk,
- in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
Cabometyx, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults.
Hepatocellular Carcinoma (HCC)
Cabometyx is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 202126/02/2021
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 201821/09/2018