What is Cabometyx - Cabozantinib used for?
Cabometyx is an anticancer medicine used to treat advanced renal cell carcinoma (a type of kidney cancer) in adult patients who have previously been treated with another anticancer called "vascular endothelial growth factor inhibitor (VEGF)".
Cabometyx contains the active ingredient cabozantinib.
How is Cabometyx - Cabozantinib used?
Cabometyx can only be obtained with a prescription and treatment should only be started by a doctor experienced in the use of anticancer 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 for one hour after taking the Cabometyx dose. The dosage may need to be reduced or the treatment temporarily interrupted if serious or unacceptable side effects occur. Treatment should be continued as long as the patient benefits or until the side effects become unsustainable. For more information, see the package leaflet.
How does Cabometyx - Cabozantinib work?
The active substance in Cabometyx, cabozantinib, is a "tyrosine kinase inhibitor". This means that it works by blocking the activity of some enzymes called tyrosine kinases. These enzymes are found in some receptors (such as MET, AXL, RET and VEGF receptors) within tumor cells, where they activate different processes, including cell division and the growth of new blood vessels destined to feed cancer. By blocking the activity of these enzymes in cancer cells, the medicine reduces the growth and spread of cancer.
What benefit has Cabometyx - Cabozantinib shown during the studies?
Cabometyx was evaluated in one main study involving 658 adult patients with advanced renal cell carcinoma, which had worsened despite treatment with a VEGF inhibitor. During the study, Cabometyx was compared to the antitumor everolimus. The results showed that Cabometyx is effective in prolonging the patient's survival period without worsening the disease (progression-free survival): the average period without worsening the disease was 7.4 months in patients receiving Cabometyx compared to 3, 8 months in patients treated with everolimus. Furthermore, preliminary results showed that patients receiving Cabometyx survived overall longer than those treated with everolimus (an average of 21.4 months compared to 16.5 months).
What are the risks associated with Cabometyx - Cabozantinib?
The most common side effects with Cabometyx (seen in at least 1 in 4 people) are diarrhea, tiredness, nausea, loss of appetite, palmar-plantar erythrodysaesthesia syndrome (also called "hand-foot syndrome", which manifests as a rash and numbness of palms and soles of feet), hypertension, vomiting, weight loss and constipation. The most common serious side effects are abdominal pain, pleural effusion (fluid accumulation around the lungs), diarrhea and nausea.
For the full list of limitations and side effects reported with Cabometyx, see the package leaflet.
Why has Cabometyx - Cabozantinib been approved?
Patients with advanced renal cell carcinoma who have previously received therapy have negative outcomes and significant unmet medical needs. Cabometyx has been shown to significantly increase the period without the disease getting worse. The first results also showed that Cabometyx contributed to prolonging patient survival. The safety profile of Cabometyx is similar to that of other tyrosine kinase inhibitors used in renal cell carcinoma and its side effects are considered manageable. The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Cabometyx's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Cabometyx - Cabozantinib?
The company that markets Cabometyx will provide the final results relating to the overall survival of the patients in the main study.
Recommendations and precautions to be followed by healthcare professionals and patients for Cabometyx to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.
More information on Cabometyx - Cabozantinib
For the full EPAR of Cabometyx, consult the website of the Agency: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Cabometyx therapy read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
