Cabometyx
Authorised
This medicine is authorised for use in the European Union
cabozantinib
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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 can only be obtained with a prescription and treatment should be started by a doctor who has experience of using cancer medicines.
Cabometyx is available as tablets. The recommended dose is 60 mg once a day. Patients should not eat for at least two hours before and one hour after taking Cabometyx. The dose may need to be reduced or treatment stopped temporarily if serious or unacceptable side effects occur. Treatment is continued for as long as the patient benefits from it or until side effects become unacceptable.
For more information about using Cabometyx, see the package leaflet or contact your doctor or pharmacist.
The active substance in Cabometyx, cabozantinib, is a tyrosine kinase inhibitor. This means that it blocks the activity of enzymes known as tyrosine kinases. These enzymes can be found in certain receptors in cancer cells, where they are involved in activating processes that include cell division and the growth of new blood vessels to supply the cancer. By blocking the activity of these enzymes in cancer cells, the medicine reduces the growth and spread of the cancer.
Renal cell carcinoma
One main study involving 658 adults with advanced renal cell carcinoma that had got worse despite treatment with a VEGF inhibitor showed that Cabometyx is effective at prolonging the time patients lived without their disease getting worse (progression-free survival). In the study, Cabometyx was compared with the cancer medicine everolimus. Patients treated with Cabometyx lived for an average of 7.4 months without their disease getting worse compared with 3.8 months in patients treated with everolimus. In addition, results indicated that patients treated with Cabometyx lived overall longer than patients treated with everolimus (an average of 21.4 months compared with 16.5 months).
A second main study showed that Cabometyx was effective in adults with previously untreated renal cell carcinoma that was locally advanced or had spread elsewhere in the body. The study involved 157 patients, and compared Cabometyx with another cancer medicine, sunitinib. Patients treated with Cabometyx lived for an average of 8.6 months without their disease getting worse compared with 5.3 months in those treated with sunitinib.
Hepatocellular carcinoma
One main study involving 707 adults with hepatocellular carcinoma who had already been treated with sorafenib showed that Cabometyx was effective at prolonging how long patients lived (overall survival). In the study, Cabometyx was compared with placebo (a dummy treatment). Patients treated with Cabometyx lived on average for 10.2 months, compared with 8.0 months in patients who received placebo.
Differentiated thyroid carcinoma
One main study involved 187 adults with differentiated thyroid carcinoma that had got worse despite previous treatment. Patients treated with Cabometyx lived for an average of 11 months without the disease getting worse compared with 2 months for patients who received placebo. In addition, results indicated that patients treated with Cabometyx lived overall longer than patients on placebo (an average of 17 months compared with 14 months).
The most common serious side effects (which may affect more than 1 in 100 people) with Cabometyx in patients with renal cell carcinoma are abdominal pain (belly ache), high blood pressure, diarrhoea, nausea (feeling sick), vomiting, loss of appetite, dizziness, tiredness, dehydration, hyponatraemia and hypomagnesaemia (low blood levels of sodium and magnesium), palmar-plantar erythrodysaesthesia syndrome (hand-foot syndrome, which involves rash and numbness on the palms and soles), weakness, embolism (clot in a blood vessel) and pulmonary embolism (clot in a blood vessel in the lungs).
The most common serious side effects (which may affect more than 1 in 100 people) with Cabometyx in patients with hepatocellular carcinoma are hepatic encephalopathy (harmful effects on the brain caused by liver damage), tiredness, vomiting, abdominal pain, hyponatraemia, palmar-plantar erythrodysaesthesia syndrome, weakness, diarrhoea and low levels of platelets in the blood.
The most common serious side effects (which may affect more than 1 in 100 people) with Cabometyx in patients with differentiated thyroid carcinoma are diarrhoea, pulmonary embolism (clot in a blood vessel in the lungs), dyspnoea (difficulty breathing), deep vein thrombosis (blood clot in a deep vein, usually the leg), hypertension (high blood pressure) and hypocalcaemia (low blood levels of calcium).
For the full list of side effects and restrictions with Cabometyx, see the package leaflet.
In advanced renal cell carcinoma, Cabometyx was shown to prolong the time patients who had previously been treated lived without their disease getting worse. These patients have poor outcomes and a high unmet medical need. Results also indicated that Cabometyx helped patients to live longer. In previously untreated patients with moderate or high-risk disease, Cabometyx also provided clinically relevant benefit, delaying the progression of the cancer and the need for other treatments.
In hepatocellular carcinoma, Cabometyx was shown to prolong survival in patients who had been treated with sorafenib. The improvement in survival is considered significant considering that these patients have poor outcomes and few treatment options.
A clinically significant benefit was also seen in patients with differentiated thyroid carcinoma.
The side effects of Cabometyx are similar to other tyrosine kinase inhibitors, and they are considered manageable.
The European Medicines Agency therefore decided that Cabometyx’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cabometyx have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Cabometyx are continuously monitored. Side effects reported with Cabometyx are carefully evaluated and any necessary action taken to protect patients.
Cabometyx received a marketing authorisation valid throughout the EU on 9 September 2016.
Further information on Cabometyx can be found on the Agency’s website: ema.europa.eu/en/medicines/human/EPAR/cabometyx.
This overview was last updated in 04-2022.
Product information
Latest procedure affecting product information:
VR/0000263255
15/04/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Product details
- Name of medicine
- Cabometyx
- Active substance
- cabozantinib (s)-malate
- International non-proprietary name (INN) or common name
- cabozantinib
- Therapeutic area (MeSH)
- Carcinoma, Renal Cell
- Carcinomas, Hepatocellular
- Anatomical therapeutic chemical (ATC) code
- L01EX07
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
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.
News on Cabometyx
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