Bristol-Myers Squibb granted NDA for ixabepilone

Jun 20 2007

Bristol-Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the New Drug Application (NDA) for the investigational compound ixabepilone, an epothilone B analog.

The proposed indications for ixabepilone are as a monotherapy to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline, a taxane, and capecitabine and in combination with capecitabine to treat patients with metastatic or locally advanced breast cancer after failure of an anthracycline and a taxane. Currently, there are few proven treatment options available to patients with breast cancer whose disease has rapidly progressed through or whose disease is not responding to prior treatment with chemotherapies (anthracycline and taxane).

Bristol-Myers Squibb also announced that the NDA has been granted priority review. The target action date is in late October.

Ixabepilone is an investigational compound, a semisynthetic analog of epothilone B, designed to inhibit or prevent the growth or development of cancer cells. Epothilones and their analogs are a potential new class of antineoplastic, chemotherapy agents. For information on ixabepilone clinical trials, log on to www.clinicaltrials.gov.

The American Cancer Society estimates that more than 180,000 new cases of breast cancer will be diagnosed in the United States this year, and almost 41,000 people will die from the disease. Metastatic breast cancer is the most advanced form of the disease in which the cancer has spread to other organs in the body. Unlike cancer that has remained contained in the breast and surrounding lymph nodes, once the cancer has spread to other organs, the disease cannot be cured; however, it can be treated.