Sprycel of Bristol Myer Squibb and Otsuka Pharamceutical is now approved to be used for the treatment of adult patients with newly diagnosed Philadelphia positive chronic myeloid leukemia in chronic phase in the US.
Chromic myeloid leukemia is a slow-growing type of leukemia. Philadelphia chromosome is condition in which patients' chromosomes (9 and 22) were recombined inappropriately and lead to defective BCR-ABL genes which send signals that lead to the overproduction of white blood cells. CML can affect both adults and children but higher incidence is observed in adult population.
Normal white blood cell values is 4 to 11 x 10^9 / L. Patients with chronic myeloid leukemia often have uncontrolled number of abnormal white blood cells production. Hence, their white blood cell count will be higher than this.
Sprycel or dasatinib is originally approved in 2006. Dasatinib is a kinase inhibitor that can inhibits BCR-ABL, SRC family, c-KIT, EPHA2, and PDGFR-beta. It is predicted to bind to multiple conformations of the ABL kinases.
Sprycel was discovered and developed by Bristol-Myers Squibb. BMS and Otsuka are collaborative partners in the commercialization of Sprycel in the US, Japan, and major EU countries.
It was approved originally through the accelerated FDA approval process in 2006 as the treatment for adults for all phases of Ph+ chronic, accelerated, or myeloid or lymphoid blast phase (CML) with resistance or intolerance to prior therapy including Gleeve. In 2009, the FDA granted Sprycel its full approval.
Sprycell is now indicated for the following:
- Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
- Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy