The new drug application (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.
A priority review means that the FDA has committed to reviewing the drug within six months of the date the NDA was submitted, rather than the standard 10 months. In this case, the NDA was submitted at the end of December 2005, meaning the FDA should take action on the application by the end of June 2006.
Dasatinib was discovered and is being developed by scientists within Bristol-Myers Squibb laboratories.