Drugs Xagena
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.
Ixempra was expected to be used to treat breast cancer that is locally advanced or metastatic. It was to be used in combination with Capecitabine ( Xeloda ) when previous treatment with cytotoxic medicines had failed.
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.
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 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, which was a severe and common side effect in patients taking the medicine.
The benefits of Ixempra in the treatment of breast cancer did not outweigh the identified risks. ( Xagena )
Source: EMA, 2009
XagenaMedicine_2009
