o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/350414/2010

EMEA/H/C/000073

EPAR summary for the public

Taxotere

docetaxel

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

What is Taxotere?

Taxotere is a medicine that contains the active substance docetaxel. It is available in two forms:

•    as two vials (one containing a concentrated solution and the other containing a solvent), whose contents are mixed together before being made up into a solution for infusion (drip into a vein);

•    a single vial containing a concentrate that is ready to make up into a solution for infusion.

What is Taxotere used for?

Taxotere is used to treat the following types of cancer:

•    breast cancer. Taxotere can be used on its own after other treatments have failed. It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;

•    non-small-cell lung cancer. Taxotere can be used on its own after other treatments have failed. It can also be used with cisplatin (another anticancer medicine) in patients who have not yet received any treatment for their cancer;

•    prostate cancer, when the cancer does not respond to hormonal treatment. Taxotere is used with prednisone or prednisolone (anti-inflammatory medicines);

7 Westferry Circus • Canary Wharf • London E14 4HB • United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail info@ema.europa.eu Website www.ema.europa.eu

© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

•    gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. Taxotere is used with cisplatin and 5-fluorouracil (other anticancer medicines);

•    head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). Taxotere is used with cisplatin and 5-fluorouracil.

For full details, see the summary of product characteristics (also part of the EPAR).

The medicine can only be obtained with a prescription.

How is Taxotere used?

Taxotere should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.

Taxotere is given as a one-hour infusion every three weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated. Taxotere is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm³). An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxotere infusion. For more information, see the summary of product characteristics.

How does Taxotere work?

The active substance in Taxotere, docetaxel, belongs to the group of anticancer medicines known as the taxanes. Docetaxel blocks the ability of cells to destroy the internal 'skeleton' that allows them to divide and multiply. With the skeleton still in place, the cells cannot divide and they eventually die. Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.

How has Taxotere been studied?

Taxotere has been studied in over 4,000 breast-cancer patients, around 2,000 non-small-cell-lung-cancer patients, 1,006 prostate-cancer patients, 457 gastric-adenocarcinoma patients and 897 head-and neck-cancer patients. In most of these studies, Taxotere was combined with other anticancer treatments and compared either with combinations of different treatments or with the same treatments but without Taxotere. The main measures of effectiveness were the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long the patients survived.

What benefit has Taxotere shown during the studies?

Adding Taxotere to other anticancer treatments produced increases in the number of patients whose cancer responded to treatment, how long the patients lived without their disease getting worse and how long the patients survived, in all five types of cancer. When used on its own, Taxotere was at least as effective as and sometimes more effective than the comparator medicines in breast cancer, and more effective than best supportive care (any medicines or techniques to help patients, but not other anticancer medicines) in lung cancer.

What is the risk associated with Taxotere?

The most common side effects with Taxotere (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils), anaemia (low red blood cell counts), thrombocytopenia (low blood platelet

Taxotere

EMA/228322/2012    Page 2/3

counts), febrile neutropenia (neutropenia with fever), peripheral sensory neuropathy (nerve damage in the hands and feet), peripheral motor neuropathy (damage to the nerves causing difficulty co-ordinating movements), dysgeusia (taste disturbances), dyspnoea (difficulty breathing), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss), skin reactions, nail disorders, myalgia (muscle pain), loss of appetite, infections, fluid retention, asthenia (weakness), pain and hypersensitivity (allergic reactions). These side effects may be more severe when Taxotere is used with other anticancer medicines. For the full list of all side effects reported with Taxotere, see the package leaflet.

Taxotere must not be used in people who are hypersensitive (allergic) to docetaxel or any of the other ingredients. Taxotere must not be used in patients who have a neutrophil count of less than 1,500 cells/mm³ or who have severe problems with their liver.

Why has Taxotere been approved?

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

Other information about Taxotere:

The European Commission granted a marketing authorisation valid throughout the European Union for Taxotere on 27 November 1995. The marketing authorisation is valid for an unlimited period.

The full EPAR for Taxotere 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 Taxotere, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 03-2012.

Taxotere

EMA/228322/2012