Bristol-Myers/Otsuka get US FDA priority review for Sprycel in chronic myeloid leukemia

The US Food and Drug Administration has accepted for filing and review US drug major Bristol-Myers Squibb and Japan headquartered Otsuka Pharmaceutical's supplemental New Drug Application (sNDA) for Sprycel (dasatinib) for the treatment of adult patients with newly-diagnosed chronic myeloid leukemia (CML) in chronic phase.

The companies also announced that the application has been granted a priority review designation by the FDA. Based on the FDA's six month goal for completing priority reviews, the projected agency action date is October 28, 2010. The filing is based on the results of the DASISION trial.

Sprycel has been available on the US market since 2006 for treating adults in all stages of
CML - chronic, accelerated, or myeloid or lymphoid blast phase- who failed to respond adequately to prior therapies including Novartis' Gleevec (imatinib mesylate).The drug registered first-quarter 2010 sales of $131 million, up 49% on the like 2009 period, for B-MS.