Breaking News From Pharma & Bio Ingredients
BMS Submits NDA for Dasatinib
Posted on 2005-12-28 11:54:00
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.
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 U.S. this year.
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