What is Afinitor?
Afinitor is a medicine that contains the active substance everolimus. It is available in pale yellow oblong tablets (5 and 10 mg).
What is Afinitor used for?
Afinitor is used to treat patients with advanced renal cell carcinoma (renal cancer that has already begun to spread). It is used when the cancer has got worse during or after treatment with targeted therapy against vascular endothelial growth factor (VEGF). VGEF is a protein that stimulates the formation of blood vessels. Because the number of patients with kidney cancer is low, the disease is considered "rare" and Afinitor was designated an "orphan medicine" (a medicine used in rare diseases) on 5 June 2007. The medicine can only be obtained with a prescription. .
How is Afinitor used?
Treatment with Afinitor should be started and supervised by a physician experienced in the treatment of cancer. The recommended dose of Afinitor is 10 mg once a day. Treatment should continue until the patient benefits or until unacceptable side effects occur. Your doctor may reduce the dose or stop treatment for a short time if the patient has serious or intolerable side effects. The tablets should be swallowed whole at the same time each day and should not be chewed or crushed. They must be taken regularly on a full or empty stomach.
How does Afinitor work?
The active substance in Afinitor, everolimus, is an anticancer medicine that acts by inhibiting a particular protein called the "specific rapamycin target for mammals" (mTOR). Once inside the body, everolimus binds to a protein found in cells and produces a "complex" that then blocks the mTOR. Because mTOR is involved in the control of cell division and the growth of blood vessels, Afinitor prevents the division of cancer cells and reduces their blood supply. This slows down the growth and spread of renal carcinoma.
What studies have been carried out on Afinitor?
The effects of Afinitor were first tested in experimental models before being studied in humans. Afinitor was compared with a placebo (a dummy treatment) in one main study involving 416 patients with advanced renal cell carcinoma who had worsened within six months of stopping treatment with medicines that targeted VGEF (sunitib, sorafenib, or both) . All patients also received the best supplementary therapies (any medicine or technique to help patients, but no other anticancer medicines). The main measure of effectiveness was the survival time without worsening the disease.
What benefit has Afinitor shown during the studies?
Afinitor was more effective than placebo in the treatment of patients with advanced renal cell carcinoma. Patients who took Afinitor lived on average 4.9 months without their disease getting worse, compared with 1.9 months for placebo-treated patients.
What is the risk associated with Afinitor?
The most common side effects reported with Afinitor (seen in more than 1 patient in 10) are infections, low levels of lymphocytes and neutrophils (types of white blood cells), hemoglobin (a protein found in red blood cells and which carries oxygen in the body ) and platelets (components that help the blood to clot), increased levels of glucose (sugar), cholesterol and triglycerides (types of fat) and phosphate, loss of appetite, abnormal taste, pneumonia (inflammation of the lungs), dyspnea (difficulty respiratory), epistaxis (loss of blood from the nose), cough, stomatitis (inflammation of the mossy covering the mouth), diarrhea, inflammation of the mucous membranes (inflammation of the wet surfaces of the body), vomiting, nausea, increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes), rashes, dry skin, itching, increased creatinine levels (degradation product of muscle metabolism), aff. atychosis, asthenia (weakness) and peripheral edema (swelling of the arms and legs). For the full list of all side effects reported with Afinitor, see the Package Leaflet. Afinitor should not be used in people who may be hypersensitive (allergic) to everolimus or other rapamycin derivatives (substances with a structure similar to everolimus) or to any of the other ingredients.
Why has Afinitor been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Afinitor's benefits are greater than its risks for the treatment of patients with advanced renal cell carcinoma whose disease had progressed further or after treatment with VEGF-targeted therapy. The committee recommended that Afinitor be given marketing authorization.
More information on Afinitor
On 3 August 2009, the European Commission granted a marketing authorization for Afinitor, valid throughout the European Union, to Novartis Europharm Limited. For a summary of the opinion of the Committee for Orphan Medicinal Products on Afinitor, click here. For the full EPAR for Afinitor click here.
Last update of this summary: 06-2009
