Ixempra
Application withdrawn
The application for this medicine has been withdrawn
MedicineHumanApplication withdrawn
Latvian is available via eTranslation, the European Commission's machine translation service.
Translate to Latvian | Important information about machine translation
- Application under evaluation
- Withdrawal of application
Overview
On 18 March 2009, Bristol-Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ixempra, for the treatment of locally advanced or metastatic breast cancer.
Ixempra is a medicine that contains the active substance ixabepilone. It was to be available as a powder and a solvent to be made up into a solution for infusion (drip into a vein).
Ixempra was expected to be used to treat breast cancer that is locally advanced or metastatic (when the tumour is large or has begun to spread within the body). It was to be used in combination with capecitabine (another anticancer medicine) when previous treatment with cytotoxic medicines (medicines that kill cells that are dividing, such as cancer cells) had failed.
The active substance in Ixempra, ixabepilone, is a cytotoxic medicine that belongs to a group of medicines called the 'epothilones'. Ixabepilone is expected to block the ability of cells to modify the internal 'skeleton' that they need to divide and multiply. With the skeleton unable to change, the cancer cells cannot divide and they eventually die. Ixabepilone is also expected to affect non-cancer cells such as nerve cells, which could cause side effects.
The effects of Ixempra were first tested in experimental models before being studied in humans.
Ixempra has been studied in three main studies involving women with locally advanced or metastatic breast cancer who had been treated with a number of other anticancer medicines in the past.
The first study looked at Ixempra given on its own in 128 women, but did not compare it with any other treatment. The main measure of effectiveness was the number of patients whose cancer responded to treatment.
The other two studies compared the effects of capecitabine given on its own with the effects of Ixempra given in combination with capecitabine in a total of 1,973 women. The main measures of effectiveness were how long the patients lived without their cancer getting worse and how long they survived.
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.
The CHMP had given a negative opinion and did not recommend a marketing authorisation for Ixempra for the treatment of locally advanced or metastatic breast cancer.
The CHMP was concerned that Ixempra's benefits in terms of increasing the time until the cancer got worse did not outweigh the concerns over the medicine's safety. In particular, the Committee was concerned over the risk of patients developing neuropathy (damage to nerve cells), which was a severe and common side effect in patients taking the medicine.
Therefore, at the time of the withdrawal, the CHMP's view was that the benefits of Ixempra in the treatment of breast cancer did not outweigh the identified risks.
The letter from the company notifying the EMEA of the withdrawal of the application is available under the tab 'All documents'.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Ixempra and that patients receiving Ixempra as part of a compassionate use programme will continue to receive the medicine. If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Key facts
- Name of medicine
- Ixempra
- Therapeutic area (MeSH)
- Breast Neoplasms
- EMA product number
- EMEA/H/C/000930
- Marketing authorisation applicant
- Bristol-Myers Squibb Pharma EEIG
- Withdrawal of application
- 18/03/2009
Temati
This page was last updated on