Bristol-Myers Squibb Company has completed the rolling submission of its new drug application (NDA) to the US Food and Drug Administration for dasatinib to treat chronic myelogenous leukaemia (CML) in chronic, accelerated or blast phases, as well as Philadelphia chromosome- positive (Ph+) acute lymphoblastic leukaemia (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, states a company release.
Dasatinib was discovered and is being developed by scientists within Bristol-Myers Squibb laboratories.
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.
Approximately 95 per cent of people with CML and approximately 25 per cent 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).
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