Drug

CABOMETYX®

cabozantinib

Cabometyx 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.

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 (20, 40 and 60 mg). 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.

In advanced renal cell carcinoma, Cabometyx was shown to prolong the time previously treated patients 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 observed is considered significant considering that these patients have poor outcomes and few treatment options available.

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.

What are the risks associated with Cabometyx?

The most common serious side effects (seen in more than 1 person in 100) with Cabometyx in patients with renal cell carcinoma are high blood pressure, diarrhoea, nausea (feeling sick), loss of appetite, 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) and embolism (clot in a blood vessel).

The most common serious side effects (seen in more than 1 person in 100) with Cabometyx in patients with hepatocellular carcinoma are hepatic encephalopathy (harmful effects on the brain caused by liver damage), palmar-plantar erythrodysaesthesia syndrome, weakness and diarrhoea.

Owner of copyright and other intellectual property rights to European Medicines Agency

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