IxempraTreatment for Breast Cancer
Update: Ixempra Now FDA Approved - October 16, 2007
FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone
PRINCETON, N.J., June 19, 2007 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb 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.
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.
About Breast Cancer
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.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
Visit Bristol-Myers Squibb on the World Wide Web at www.bms.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the application will be approved, or, if approved, that the product will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2006 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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Posted: June 2007
- FDA Approves Ixempra (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer - October 17, 2007