FDA News

FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone

(June 19, 2007)-- Bristol-Myers Squibb 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).

Share or bookmarklet this web page at: