What is Torisel?
Torisel is a concentrate and diluent to obtain a solution for infusion (drip into a vein) that contains the active substance temsirolimus.
What is Torisel used for?
Torisel is indicated for the treatment of patients with the following types of carcinoma:
- advanced renal cell carcinoma (a type of kidney cancer). "Advanced" means that the cancer has begun to spread;
- mantle cell lymphoma (an aggressive carcinoma of a type of white blood cell called B-lymphocytes). Torisel is used in adult patients whose lymphoma has recurred after previous treatment or who have not responded to other treatments.
Because the number of patients with renal cell carcinoma or mantle cell lymphoma is reduced. These diseases are considered "rare" and Torisel was designated an "orphan medicine" (a medicine used in rare diseases) on 6 April 2006 (for renal cell carcinoma) and 6 November 2006 (for mantle cell lymphoma) .
The medicine can only be obtained with a prescription.
How is Torisel used?
Torisel should be administered under the supervision of a doctor who has experience in the use of anticancer medicines.
For renal cell carcinoma, the recommended dose is 25 mg once a week. For mantle cell lymphoma, the dose is 175 mg once a week for three weeks, followed by weekly doses of 75 mg.
Torisel is given as an infusion lasting 30-60 minutes. About 30 minutes before the start of each dose of Torisel, patients should be treated with an antihistamine to prevent allergic reactions. Treatment with Torisel should continue until the patient ceases to benefit from the medicine or until unacceptable side effects occur. Management of these effects may require interruption or dose reduction.
How does Torisel work?
The active substance in Torisel, temsirolimus, is an anticancer medicine that works by blocking a protein called the "rapamycin target in mammals" (mTOR). In the organism, temsirolimus
binds to a protein present in the cells forming a "complex". This complex inhibits the activity of mTOR. Because mTOR is involved in the control of cell division, Torisel causes a halt in the division of cancer cells, slowing down the growth and spread of the tumor.
What studies have been carried out on Torisel?
Regarding advanced renal cell carcinoma, the effects of Torisel were analyzed in a main study involving 626 patients with poor prognosis. The study compared the efficacy of a 25 mg dose of Torisel given once a week with that of interferon alfa (another anticancer medicine) and with the effectiveness of the combination of 15 mg of Torisel once a week in combination with alpha interferon. The main measure of effectiveness was the survival time of the patients.
Regarding mantle cell lymphoma, Torisel has been studied in 162 patients whose disease had recurred after previous treatment or who had not responded to other treatments. Each patient received one or two doses of Torisel, or the most appropriate alternative treatment chosen by the investigator from a list of medicines commonly used to treat this type of cancer, such as gemcitabine and fludarabine. The main measure of effectiveness was the time to progression of the disease.
What benefit has Torisel shown during the studies?
Torisel was more effective than comparative treatments for both types of cancer.
With regard to advanced renal cell carcinoma, patients who received Torisel as monotherapy survived an average of 10.9 months compared to the average of 7.3 months in subjects treated with interferon alfa alone. Subjects treated with the lowest dose of Torisel associated with interferon alfa survived for a similar average period (8.4 months) in patients treated with interferon alfa alone.
Regarding the mantle cell lymphoma, patients treated with the approved dose of Torisel survived on average 4.8 months before disease progression, compared to the average of 1.9 months of subjects treated with a treatment chosen by the investigator .
What is the risk associated with Torisel?
The most common side effects with Torisel (seen in more than 1 patient in 10) are bacterial and viral infections, pneumonia (lung infection), urinary tract infections (infections of the urine-carrying apparatus), pharyngitis (pain throat), upper respiratory tract infection (colds), rhinitis (blocked and runny nose), thrombocytopenia (low platelet count in the blood), anemia (decreased number of red blood cells in the blood), neutropenia (low number of neutrophils, a type of white blood cells in the blood), leukopenia (low number of white blood cells in the blood), lymphopenia (low level of lymphocytes, a type of white blood cells in the blood), hypokalemia (low potassium levels), loss of appetite, hyperglycemia (high levels blood sugar), diabetes, hypercholesterolemia (high cholesterol levels in the blood), hyperlipemia (high levels of fat in the blood), insomnia, anxiety, dysgeusia (distortion of taste), dyspnoea (difficulty res pirare), epistaxis (nosebleed), cough, abdominal pain (stomach ache), vomiting, stomatitis (inflammation of the walls of the mouth), diarrhea, nausea, rash, itching, acne, nail problems, skin dryness, mal back pain, arthralgia (joint pain), myalgia (muscle pain), edema (swelling), asthenia (weakness), pain, pyrexia (fever), mucositis (inflammation of the body's wet surfaces), chest pains, chills and increased blood creatinine levels (a marker of kidney disorders). For the full list of all side effects reported with Torisel, see the Package Leaflet.
Torisel must not be used in people who may be hypersensitive (allergic) to temsirolimus, its metabolites (substances produced by its degradation) including sirolimus (a drug used to prevent kidney transplant rejection), polysorbate 80 or any other of the other components of the medicine. Torisel should not be used in patients with mantle cell lymphoma with moderate to severe liver disorders.
Why has Torisel been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Torisel's benefits are greater than its risks in the first-line treatment of patients with advanced renal cell carcinoma presenting at least three out of six prognostic risk factors as well as for treatment of adult patients with recurrent and / or refractory mantle cell lymphoma.
The committee recommended that Torisel be given marketing authorization.
More information on Torisel:
On 19 November 2007, the European Commission granted Torethel a marketing authorization valid throughout the European Union to Wyeth Europa Ltd.
For summaries of the opinion of the Committee for Orphan Medicinal Products click here (for renal cell carcinoma) and here (for mantle cell lymphoma).
For the full EPIS of Torisel click here.
Last update of this summary: 08-2009.
