Bristol-Myers Squibb Company recently announced that the FDA has granted approval of IXEMPRA™ (ixabepilone) 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. The FDA has also granted approval of IXEMPRA 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. IXEMPRA is a microtubule inhibitor belonging to a class of antineoplastic agents, the epothilones. Bristol-Myers Squibb anticipates that IXEMPRA will be available within days. “Previously, patients with aggressive metastatic or locally advanced breast cancer no longer responding to currently available chemotherapies had limited treatment options,” said Linda Vahdat, M.D., Associate Professor of Clinical Medicine and Associate Attending Physician, New York-Presbyterian Hospital/Weill Cornell Medical Center. “The approval of IXEMPRA means that we now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies.” “Bristol-Myers Squibb has a rich history in oncology spanning more than 40 years, and we are extremely proud that IXEMPRA has been approved as it is a significant addition to the Bristol-Myers Squibb oncology portfolio and addresses a serious unmet medical need in the treatment of patients with metastatic or locally advanced breast cancer,” said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. The FDA reviewed the efficacy and safety of IXEMPRA based on the analysis of two multi-center, multinational trials that included 878 patients and evaluated IXEMPRA either as a monotherapy or in combinationwith capecitabine in patients with metastatic or locally advanced breast cancer.
