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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/381437/2015

EMEA/H/C/002018

EPAR summary for the public

Jevtana

cabazitaxel

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

What is Jevtana?

Jevtana is a cancer medicine that contains the active substance cabazitaxel. It is available as a concentrate and a solvent to be made up into a solution for infusion (drip) into a vein.

What is Jevtana used for?

Jevtana is used to treat men with hormone refractory metastatic prostate cancer. This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in semen. Jevtana is used when the cancer has spread to other parts of the body (metastatic) and has stopped responding to hormonal treatment (hormone refractory). It is used in combination with prednisone or prednisolone (anti-inflammatory medicines) in patients who have previously been treated with docetaxel (another cancer medicine).

The medicine can only be obtained with a prescription.

How is Jevtana used?

Jevtana should only be used in units specialising in chemotherapy (medicines to treat cancer) under the supervision of a doctor experienced in the use of chemotherapy.

Jevtana is given once every three weeks as an infusion lasting one hour, at a dose of 25 mg per square metre body surface area (calculated using the patient's weight and height). It is given in combination with prednisone or prednisolone, taken daily throughout treatment. The dose of Jevtana should be reduced if the patient experiences certain side effects, and treatment should be stopped if side effects

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continue at a reduced dose of 20 mg/m². The doses should also be lower in patients with mildly or moderately reduced liver function.

Before receiving Jevtana infusions, patients should first be given anti-allergic medicines to reduce the risk of allergic reactions and anti-emetic medicines to prevent vomiting.

How does Jevtana work?

The active substance in Jevtana, cabazitaxel, belongs to the group of cancer medicines known as 'taxanes'. Cabazitaxel works by blocking the ability of cancer cells to break down their internal 'skeleton' that allows them to divide and multiply. With their skeleton still in place, the cells cannot divide and they eventually die. Jevtana also affects non-cancer cells, such as blood and nerve cells, which can cause side effects.

How has Jevtana been studied?

The effects of Jevtana were first tested in experimental models before being studied in humans.

Jevtana was investigated in one main study involving 755 men with hormone refractory metastatic prostate cancer who had previously been treated with docetaxel. The effects of Jevtana were compared with another cancer medicine, mitoxantrone. Both medicines were given in combination with daily prednisone or prednisolone. The main measure of effectiveness was overall survival (the average length of time the patients lived).

What benefit has Jevtana shown during the studies?

In the main study, Jevtana prolonged overall survival compared with the comparator medicine mitoxantrone. The average overall survival for patients treated with Jevtana was 15.1 months compared with 12.7 months for patients given mitoxantrone.

What is the risk associated with Jevtana?

The most common side effects with Jevtana (seen in more than 1 patient in 10) include anaemia (low red blood cell counts), leucopenia (low white blood cell counts), neutropenia (low counts of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts) and diarrhoea. Some of these effects were severe. For the full list of all side effects reported with Jevtana, see the package leaflet.

Jevtana should not be used in people who may be hypersensitive (allergic) to cabazitaxel, to any other taxane, or to any of the other ingredients. It must not be given to patients whose blood neutrophil count is below 1,500/mm³, who have severely reduced liver function or who recently received or are about to receive a yellow fever vaccine.

Why has Jevtana been approved?

The CHMP considered that the ability of Jevtana to prolong overall survival in hormone refractory metastatic prostate cancer patients was clinically important. It decided that Jevtana's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Jevtana?

A risk management plan has been developed to ensure that Jevtana is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jevtana, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Jevtana

The European Commission granted a marketing authorisation valid throughout the European Union for Jevtana on 17 March 2011.

The full EPAR for Jevtana can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Jevtana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2015.

Jevtana

EMA/381437/2015

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