Ixabepilone Approved for the Treatment of Advanced Breast Cancer

The US Food and Drug Administration (FDA) has granted approval of ixabepilone (Ixempra) as monotherapy for the treatment of patients with metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine (Xeloda). The FDA has also granted approval of ixabepilone in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline, and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated.

The FDA reviewed the efficacy and safety of ixabepilone based on the analysis of two multicenter, multinational trials that included 878 patients and evaluated the drug either as a monotherapy or in combination with capecitabine in patients with metastatic or locally advanced breast cancer.