Docetaxel Accord | European Medicines Agency (EMA)

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Overview

Docetaxel Accord is a cancer medicine 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 cancer medicines (capecitabine, cyclophosphamide, doxorubicin or trastuzumab) in patients who have not yet received 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 cancer medicine) in patients who have not yet received any treatment for their cancer;
prostate cancer that has spread to other parts of the body (metastatic). Docetaxel Accord is used with androgen-deprivation therapy (therapy greatly reducing the body’s production of testosterone) when such treatment still works. Docetaxel Accord is used with prednisone or prednisolone (anti-inflammatory medicines) when the cancer is castration resistant (androgen- deprivation therapy does not work);
metastatic gastric adenocarcinoma (a stomach cancer) in patients who have not yet received any treatment for metastatic cancer. Docetaxel Accord is used with cisplatin and fluorouracil (other cancer 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 fluorouracil.

Docetaxel Accord is a ‘generic medicine’. This means that Docetaxel Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Taxotere. For more information on generic medicines, see the question-and-answer document below.

Docetaxel Accord contains the active substance docetaxel.

Docetaxel Accord can only be obtained with a prescription and should only be used in units specialising in giving chemotherapy (medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.

Docetaxel Accord is given as a 1-hour infusion (drip) into a vein every 3 weeks. The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated and the patient’s weight and height. An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Accord infusion. The dose of Docetaxel Accord may need to be reduced, or treatment interrupted or discontinued, if the patient develops certain side effects.

For more information about using Docetaxel Accord, see the package leaflet or contact your doctor or pharmacist.

The active substance in Docetaxel Accord, docetaxel, belongs to the group of cancer medicines known as taxanes. Docetaxel blocks the ability of cells to break down the internal ‘skeleton’ that allows them to divide. With the skeleton still in place, the cells cannot divide and they eventually die. Because docetaxel works on dividing cells, it also affects non-cancer cells such as blood cells, which can cause side effects.

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Taxotere, and do not need to be repeated for Docetaxel Accord.

As for every medicine, the company provided studies on the quality of Docetaxel Accord. There was no need for ‘bioequivalence’ studies to investigate whether Docetaxel Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Docetaxel Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

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

The European Medicines Agency concluded that, in accordance with EU requirements, Docetaxel Accord has been shown to be comparable to Taxotere. Therefore, the Agency’s view was that, as for Taxotere, the benefits of Docetaxel Accord outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Docetaxel Accord have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Docetaxel Accord are continuously monitored. Side effects reported with Docetaxel Accord are carefully evaluated and any necessary action taken to protect patients.

Docetaxel Accord received a marketing authorisation valid throughout the EU on 22 May 2012.

English (EN)
(145.91 KB – PDF)

First published: 11/06/2012Last updated: 08/04/2020

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Product information

English (EN)
(631.25 KB – PDF)

First published: 11/06/2012Last updated: 13/02/2025

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Latest procedure affecting product information:
VR/0000246935

04/02/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(17.37 KB – PDF)

First published: 11/06/2012Last updated: 11/06/2012

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Product details

Name of medicine

Docetaxel Accord

Active substance

docetaxel

International non-proprietary name (INN) or common name

docetaxel

Therapeutic area (MeSH)

Head and Neck Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Prostatic Neoplasms
Breast Neoplasms

Anatomical therapeutic chemical (ATC) code

L01CD02

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Breast cancer

Docetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

operable node-positive breast cancer;
operable node-negative breast cancer.

For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.

Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Non-small-cell lung cancer

Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.

Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Prostate cancer

Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma

Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer

Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

More information on Docetaxel Accord

English (EN)
(66.45 KB – PDF)

First published: 09/07/2007Last updated: 07/12/2012

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