Sprycel
Generic name: dasatinib
Treatment for: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia
Bristol-Myers Squibb Submits New Drug Application for Dasatinib
PRINCETON, N.J., December 28, 2005 -- Today, Bristol-Myers Squibb Company announced that the Company has completed the rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for dasatinib to treat chronic myelogenous leukemia (CML) in chronic, accelerated or blast phases, as well as Philadelphia chromosome- positive (Ph+) acute lymphoblastic leukemia (ALL).
The NDA seeks approval of dasatinib - an investigational multi-targeted kinase inhibitor - to treat adult CML and Ph+ ALL patients with resistance or intolerance to prior therapy.
Dasatinib was discovered and is being developed by scientists within Bristol-Myers Squibb laboratories.
About CML and ALL
CML is a slowly progressing cancer of the blood and bone marrow that usually occurs during or after middle age and rarely occurs in children. ALL is a rapidly progressing cancer of the blood and bone marrow that usually occurs in children; although it can occur at any age. The Leukemia and Lymphoma Society estimates that 4,600 new cases of CML and nearly 4,000 new cases of ALL will be diagnosed in the United States this year.
About the Philadelphia Chromosome
Approximately 95 percent of people with CML and approximately 25 percent of adults with ALL have a gene mutation called the Philadelphia chromosome, in which part of the DNA from one chromosome (chromosome 9) moves to another chromosome (chromosome 22). This translocation brings together two genes, one from each chromosome: BCR (breakpoint cluster region) and ABL (Ableson leukemia virus). The resulting hybrid gene, BCR-ABL, produces an abnormal protein called Bcr/Abl tyrosine kinase that triggers uncontrolled cell growth.
Source: Bristol-Myers Squibb
Posted: December 2005
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- FDA Approves New Sprycel (Dasatinib) Product Labeling for Patients with Chronic-Phase CML - November 9, 2007
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Sprycel (dasatinib) FDA Approval History
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