Torisel

temsirolimus

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This is a summary of the European public assessment report (EPAR) for Torisel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Torisel.

What is Torisel?

Torisel is a concentrate and diluent that are made up into a solution for infusion (drip into a vein). It contains the active substance temsirolimus.

What is Torisel used for?

Torisel is used to treat patients with the following types of cancer:

  • advanced renal-cell carcinoma (a type of kidney cancer). ‘Advanced’ means that the cancer has started to spread;
  • mantle-cell lymphoma (an aggressive cancer of a type of white blood cell called B lymphocytes). Torisel is used in adults when the lymphoma has come back after previous treatment or has not responded to other treatments.

Because the numbers of patients with renal-cell carcinoma and mantle-cell lymphoma are low, the 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 on 6 November 2006 (for mantle-cell lymphoma).

The medicine can only be obtained with a prescription.

How is Torisel used?

Torisel must be given 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, but a 10-mg dose is recommended in patients with severe liver problems who have high levels of platelets in the blood before treatment. For mantle-cell lymphoma, the recommended 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 to 60 minutes. Patients should receive an antihistamine to prevent an allergic reaction around 30 minutes before each dose of Torisel. Treatment with Torisel should continue until the patient does not benefit from the medicine any more or has unacceptable side effects. Some side effects can be managed by interrupting treatment or reducing the dose.

How does Torisel work?

The active substance in Torisel, temsirolimus, is an anticancer medicine, which acts by blocking a protein called ‘mammalian target of rapamycin’ (mTOR). In the body, temsirolimus attaches to a protein that is found inside cells to make a ‘complex’. This complex then blocks mTOR. Since mTOR is involved in the control of cell division, Torisel prevents the division of cancer cells, slowing down the growth and spread of the cancer.

How has Torisel been studied?

In advanced renal-cell carcinoma, Torisel has been studied in one main study involving 626 patients who had a poor prognosis. The study compared 25 mg Torisel with interferon alfa (another anticancer medicine) and with 15 mg Torisel in combination with interferon alfa. The main measure of effectiveness was how long the patients survived. In mantle-cell lymphoma, Torisel has been studied in 162 patients whose disease had come back after previous treatment or had not responded to other treatments. Each patient received one of 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 or fludarabine. The main measure of effectiveness was how long the patients lived without the disease getting worse.

What benefit has Torisel shown during the studies?

Torisel was more effective than the comparator treatments. In advanced renal-cell carcinoma, patients receiving Torisel alone survived for an average of 10.9 months, compared with 7.3 months in those receiving interferon alfa alone. The patients receiving the lower dose of Torisel in combination with interferon alfa survived for a similar length of time (8.4 months) as those taking interferon alfa alone. In mantle-cell lymphoma, patients receiving the approved dose of Torisel lived for an average of 4.8 months without their disease getting worse, compared with 1.9 months in those receiving the alternative treatment.

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 (infection of the lungs), thrombocytopenia (low blood platelet counts), anaemia (low red-blood-cell counts), neutropenia (low levels of neutrophils, a type of white blood cell), hypokalaemia (low blood potassium levels), decreased appetite, hyperglycaemia (high blood sugar levels), hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridaemia (high blood levels of certain fats), headache, insomnia (difficulty sleeping), dysgeusia (taste disturbances), dyspnoea (difficulty breathing), epistaxis (nose bleeds), cough, abdominal pain (stomach ache), vomiting, stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), constipation, rash, pruritus (itching), dry skin, back pain, arthralgia (joint pain), oedema (swelling), fatigue, asthenia (weakness), pain, pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces), chest pain, chills and increased blood creatinine levels (a marker of kidney problems). For the full list of all side effects reported with Torisel, see the package leaflet.

Torisel must not be used in people who are hypersensitive (allergic) to temsirolimus, to its metabolites (the substances that it is broken down into) including sirolimus (a medicine used to prevent rejection of transplanted kidneys), to polysorbate 80 or to any of the other ingredients of the medicine. Torisel is not recommended in patients with mantle-cell lymphoma who have moderate or severe problems with their liver.

Why has Torisel been approved?

The CHMP decided that Torisel’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Torisel

The European Commission granted a marketing authorisation valid throughout the European Union for Torisel on 19 November 2007.

For more information about treatment with Torisel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Torisel : EPAR - Summary for the public BG = bălgarski 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public ES = español 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public CS = čeština 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public DA = dansk 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public DE = Deutsch 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public ET = eesti keel 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public EL = elliniká 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public EN = English 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public FR = français 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public IT = italiano 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public LV = latviešu valoda 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public LT = lietuvių kalba 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public HU = magyar 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public MT = Malti 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public NL = Nederlands 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public PL = polski 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public PT = português 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public RO = română 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public SK = slovenčina 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public SL = slovenščina 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public FI = suomi 22/09/2009 04/10/2012
Torisel : EPAR - Summary for the public SV = svenska 22/09/2009 04/10/2012

This EPAR was last updated on 25/11/2014 .

Authorisation details

Product details

Product details for Torisel
NameTorisel
Agency product numberEMEA/H/C/000799
Active substance

temsirolimus

International non-proprietary name (INN) or common name

temsirolimus

Therapeutic area Carcinoma, Renal CellLymphoma, Mantle-Cell
Anatomical therapeutic chemical (ATC) code L01XE09
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Torisel
Marketing-authorisation holder

Pfizer Limited

Revision21
Date of issue of marketing authorisation valid throughout the European Union19/11/2007

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom

Product information

Product information

12/11/2014  Torisel -EMEA/H/C/000799 -IB/0059/G

Name Language First published Last updated
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014
Torisel : EPAR - Product Information SV = svenska 22/09/2009 26/11/2014

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011
Torisel : EPAR - All Authorised presentations SV = svenska 05/12/2007 17/05/2011

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Renal-cell carcinoma

Torisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.

Mantle-cell lymphoma

Torisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Torisel : EPAR - Procedural steps taken before authorisation SV = svenska 05/12/2007 03/12/2010
Torisel : EPAR - Scientific Discussion SV = svenska 05/12/2007  

Authorised

This medicine is approved for use in the European Union

News

More information on Torisel