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Semisynthetic Analog of Epothilone B Granted Priority Review by FDA

PRINCETON, N.J., June 19 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb (NYSE:BMY) announced today 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.

About Ixabepilone
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.

Source: Bristol-Myers Squibb

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