The United States Food and Drug Administration (FDA) has approved Ixempra® (ixabepilone) for the treatment of advanced breast cancer. The indication includes the use of Ixempra as a single agent for the treatment of recurrent, advanced breast cancer in patients who have stopped responding to chemotherapy including anthracyclines, taxanes, and Xeloda® (capecitabine). Ixempra is also approved for the treatment of advanced breast cancer in combination with Xeloda among patients whose cancer has stopped responding to anthracyclines and taxanes or who do not respond to a taxane and are not eligible to receive further treatment with anthracyclines.
Recurrent breast cancer refers to cancer that has recurred and/or progressed following prior therapy. Patients with recurrent breast cancer that has spread to distant sites in the body have limited treatment options.Anthracyclines and taxanes are among the most commonly used classes of chemotherapy in the treatment of breast cancer.
Ixempra is a type of chemotherapy agent that is a semi-synthetic analog of Epothilone B. Ixempra prevents or reduces cancer cells from replicating. Two clinical trials prompted the FDA approval of Ixempra.
The first trial evaluated Ixempra as a single agent. This trial included 126 patients with advanced breast cancer who had stopped responding to treatment with an anthracycline, a taxane, and Xeloda. Patients who had HER2-positive (human epidermal growth factor2-positive) cancer, a specific type of cancer that accounts for approximately 25–30% of all breast cancers, had received prior therapy with Herceptin® (trastuzumab)-an agent that is targeted against HER2-positive breast cancer-and had stopped responding. Anticancer responses with Ixempra occurred in 12.4% of patients.
The second trial compared Ixempra plus Xeloda with Xeloda alone in 752 patients who had stopped responding to anthracyclines and taxanes. Treatment with Ixempra plus Xeloda significantly improved progression-free survival compared with Xeloda alone in this group of patients.
Patients with recurrent, advanced breast cancer may wish to speak with their physician regarding their individual risks and benefits of treatment with Ixempra. Ixempra is expected to be available for use with the next few days.
Reference: Bristol-Meyers Squibb. FDA Approves IXEMPRA™ (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer. Available at: http://newsroom.bms.com/index.php?s=press_releases&item=308. Accessed October 2007.