Drug

VOTRIENT®

pazopanib

Votrient Overview

This is a summary of the European public assessment report (EPAR) for Votrient. 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 Votrient.

Treatment with Votrient should only be started by a doctor who has experience in giving anticancer medicines. The recommended dose is 800 mg once a day, but this may need to be reduced if the patient has side effects. Votrient should be taken with water but without food, at least one hour before or two hours after a meal.

In patients with moderate liver problems the dose should be reduced to 200 mg once a day. Votrient is not recommended in patients with severe liver problems.

The active substance in Votrient, pazopanib, is a protein-kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases. These enzymes can be found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells, such as ‘VEGFR’, ‘PDGFR’ and ‘KIT’. By blocking these enzymes, Votrient can reduce the growth and spread of the cancer.

Votrient was more effective than placebo at treating advanced renal-cell carcinoma. On average, the patients who took Votrient lived for 9.2 months without their disease getting worse, compared with 4.2 months for the patients who took placebo.

Votrient was also more effective than placebo at treating soft-tissue sarcoma. On average, the patients who took Votrient lived for 20 weeks without their disease getting worse, compared with seven weeks for the patients who took placebo.

The CHMP considered that Votrient has been shown to be an effective medicine for patients with advanced renal-cell carcinoma and soft-tissue sarcoma, with a clinically relevant improvement in progression-free survival. The safety profile of Votrient is considered acceptable and generally manageable. Therefore, the Committee decided that Votrient’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Votrient was originally given ‘conditional approval’ because there was more evidence to come about the medicine, in particular in the treatment of renal-cell carcinoma. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Votrient on 14 June 2010. This was switched to a full marketing authorisation on 1 July 2013.

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

What are the risks associated with Votrient?

The most common side effects with Votrient (seen in more than 1 patient in 10) include reduced appetite, dysgeusia (taste disturbances), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, pain, hair colour change, fatigue (tiredness), skin hypopigmentation (discolouration of the skin), exfoliative (flaky) rash, headache, stomatitis (inflammation of the lining of the mouth), decreased weight and increased blood levels of certain liver enzymes. For the full list of all side effects reported with Votrient.

Votrient must not be used in people who are hypersensitive (allergic) to pazopanib or any of the other ingredients.

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

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