The Food and Drug Administration (FDA) has approved a new chemotherapy drug for the treatment of some cases of metastatic and locally advanced breast cancer.

Ixabepilone (Ixempra) was approved for women with advanced breast cancers that fail to respond to standard chemotherapy agents such as anthracyclines, taxanes, or capecitabine (Xeloda). Ixabepilone was also approved for use in combination with capecitabine for the treatment of advanced breast cancer in certain women, including those whose cancers have become resistant to treatment with an anthracycline and a taxane.

The drug, manufactured by Bristol-Myers Squibb, belongs to a new class of chemotherapy agents known as epothilone analogs. These medicines target proteins involved in cell division. Epothilones work in a similar manner as taxanes, but unlike the taxanes they do not require patients to be premedicated to prevent possible allergic reactions.

Approval was granted based on two multicenter trials that tested ixabepilone either as a single therapy or in combination with capecitabine in patients with metastatic or locally advanced breast cancer. One of the trials was a randomized phase III study involving 752 women. Among the combination group, the median time the disease took to progress was 5.8 months compared with 4.2 months in the capecitabine alone group.

Side effects from ixabepilone were similar in both studies and included tingling or numbness in the hands and feet, fatigue, nausea, vomiting, and muscle pain.

Ixabepilone is also being studied as a treatment for other cancers, including prostate, endometrial, kidney, and non-Hodgkin lymphoma.

NCI at APHA Be sure to visit the NCI Exhibit Booth during the American Public Health Association (APHA) Annual Meeting November 3-7 in Washington, DC. The NCI exhibit will be located in booth #1128.