Taxotere: Withdrawal of the application to change the marketing authorisation

Taxotere/Docetaxel Winthrop is a concentrate and solvent, which are made up into a solution for infusion (drip into a vein). It contains the active substance docetaxel.

Taxotere/Docetaxel Winthrop is an anticancer medicine. It is used in breast cancer that is advanced or 'metastatic' (has spread to other parts of the body), and in breast cancer that can be treated with surgery. In these patients, Taxotere/Docetaxel Winthrop is used in addition to surgery to remove the tumour, together with doxorubicin and cyclophosphamide (other anticancer medicines).

Taxotere/Docetaxel Winthrop is also used in advanced or metastatic non-small cell lung cancer, in prostate cancer, in metastatic gastric adenocarcinoma (a type of stomach cancer) and in advanced head and neck cancer.

Taxotere/Docetaxel Winthrop was also expected to be used to treat breast cancer that can be treated with surgery when the cancer has been shown to be 'expressing' large amounts of HER2: this is a type of cancer that produces (expresses) a specific protein called HER2 in large quantities on the surface of the tumour cells.

Taxotere/Docetaxel Winthrop was expected to be used in addition to surgery to remove the tumour in the following treatment combinations:

• together with trastuzumab (another anticancer medicine), following treatment with doxorubicin and cyclophosphamide;
• together with trastuzumab and carboplatin (another anticancer medicine).

In both cases, all medicines were to be started at the same time.

The active substance in Taxotere/Docetaxel Winthrop, 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 affects not only cancer cells, but also non-cancer cells such as blood cells, which can cause side effects.

Taxotere/Docetaxel Winthrop has been studied in one main study involving over 3,000 women with HER2-expressing breast cancer that could be treated with surgery. The study compared the effectiveness of the following treatment combinations, which were used in addition to surgery:

• the combination of doxorubicin and cyclophosphamide for 12 weeks, followed by Taxotere/Docetaxel Winthrop for 12 weeks, either alone or in combination with trastuzumab;
• the combination of Taxotere/Docetaxel Winthrop, trastuzumab and carboplatin for 18 weeks.

In both groups, trastuzumab treatment was continued for a year. The main measure of effectiveness was how long the patients survived until their cancer came back.

The evaluation had finished and the CHMP had given a negative opinion. The company had initiated an appeal process, but this had not yet finished when the company withdrew.

Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Taxotere/Docetaxel Winthrop in the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.

The CHMP was concerned that it was not possible to establish the benefits of the treatment combinations including Taxotere/Docetaxel Winthrop when used in addition to surgery, because of the way the single main study was designed. The CHMP was also concerned that the company did not provide sufficient clinical evidence to justify the use of the combination of Taxotere/Docetaxel Winthrop, carboplatin and trastuzumab.

Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Taxotere/Docetaxel Winthrop had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.

The letters from the company notifying the EMEA of the withdrawal of the application are available under the tab 'All documents'.

The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Taxotere/Docetaxel Winthrop. If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.

There are no consequences on the use of Taxotere/Docetaxel Winthrop in its authorised indications, for which the balance of benefits and risks remains unchanged.