Sprycel
Generic name: dasatinib
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Dasatinib
PRINCETON, N.J., March 7, 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.
Source: Bristol-Myers Squibb
Posted: March 2006
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Sprycel (dasatinib) FDA Approval History
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