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FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Dasatinib |
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07 Mar 2006 |
PRINCETON, NJ, USA | Mar 07, 2006 | Bristol-Myers Squibb Company (NYSE: BMY) today 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 dasatinib. The NDA seeks approval of dasatinib to treat chronic myelogenous leukemia, as well as Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia, in adult patients with resistance or intolerance to prior therapy.
The Company also announced that the dasatinib NDA will be reviewed for accelerated approval and has been granted a priority review. Based on the priority review, the FDA has six months from the submission date of December 28, 2005, or until June 28, 2006, to take action on the NDA.
Dasatinib was discovered and is being developed by scientists within Bristol-Myers Squibb laboratories.
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 http://www.bms.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. 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 dasatinib will receive regulatory approval or, if approved, 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, 2004 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.
SOURCE: Bristol-Myers Squibb Company |
