New Drug Option for Late-Stage Breast Cancer Patients

Sun Nov 18, 7:00 PM ET
After a swift 6-month priority review, the Food and Drug Administration put its stamp of approval on ixabepilone (IxempraTM), a new chemotherapy drug shown to reduce tumor size and slow tumor growth in some patients with metastatic or locally advanced breast cancer.
The new drug, developed by Bristol-Myers Squibb, is approved for use in combination with another chemotherapy drug capecitabine, in patients who haven't had success with an anthracycline (like doxorubicin or epirubicin) and a taxane (like paclitaxel or docetaxel), and as a standalone option for patients who have exhausted all 3 options (an anthracycline, a taxane, and capecitabine).
The FDA review was based on studies of ixabepilone alone and in combination with capecitabine. In a study of 126 breast cancer patients who received ixabepilone alone, 12% saw a significant decrease in the size of their tumors. In a randomized trial of 752 patients who took both ixabepilone and capecitabine, tumor growth slowed significantly compared to patients who were taking capecitabine alone.
Ixabepilone belongs to a class of drugs known as epothilone analogs, which work by binding to and interfering with microtubules, structures that play a key role in cell division. The net effect is a slowing of the growth of cancer cells in the body.
Ixabepilone is given by intravenous infusion over 3 hours every 3 weeks. One of the possible side effects of taking ixabepilone is bone marrow suppression, so it is not recommended for patients who have low white blood cell or platelet counts. Other possible side effects include numbness or tingling in the hands or feet, constipation, nausea, vomiting, and muscle and joint pain.