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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMEA/H/C/002539

EPAR summary for the public

Docetaxel Accord

docetaxel

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

What is Docetaxel Accord?

Docetaxel Accord is a medicine that contains the active substance docetaxel. It is available as a

concentrate to be made up into a solution for infusion (drip into a vein).

Docetaxel Accord is a 'generic medicine'. This means that Docetaxel Accord is similar to a 'reference

medicine' already authorised in the European Union (EU) called Taxotere. For more information on

generic medicines, see the question-and-answer document here.

What is Docetaxel Accord used for?

Docetaxel Accord is used to treat the following types of cancer:

•    breast cancer. Docetaxel Accord 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. Docetaxel Accord 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. Docetaxel Accord is used with prednisone or prednisolone (anti-inflammatory medicines);

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•    gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. Docetaxel Accord 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). Docetaxel Accord 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 Docetaxel Accord used?

Docetaxel Accord 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.

Docetaxel Accord 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. Docetaxel Accord 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 Docetaxel Accord infusion. For more information, see the summary of product characteristics.

How does Docetaxel Accord work?

The active substance in Docetaxel Accord, 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 Docetaxel Accord been studied?

The company provided data from published literature on docetaxel. The company also showed that the Docetaxel Accord solution for infusion has comparable quality to that of Taxotere. No additional studies were needed as Docetaxel Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere.

What are the benefits and risks of Docetaxel Accord?

Because Docetaxel Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.

Why has Docetaxel Accord been approved?

The CHMP concluded that, in accordance with EU requirements, Docetaxel Accord has been shown to be comparable to Taxotere. Therefore, the CHMP's view was that, as for Taxotere, the benefit outweighs the identified risk. The Committee recommended that Docetaxel Accord be given marketing authorisation.

Other information about Docetaxel Accord

The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Accord on 22 May 2012.

Docetaxel Accord

EMA/339088/2012    Page 2/3

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

The full EPAR for the reference medicine can also be found on the Agency's website.

This summary was last updated in 04-2012.

Docetaxel Accord EMA/339088/2012