ODAC backs Sprycel approval

FDA's Oncologic Drugs Advisory Committee unanimously recommended the accelerated approval of Sprycel dasatinib from Bristol-Myers (BMY) to treat chronic myelogenous leukemia (CML) in patients with resistance or intolerance to prior therapy, including Gleevec imatinib. The committee voted 12 to 1 with 1 abstention to recommend full approval of Sprycel for Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) in patients with resistance or intolerance to imatinib. Sprycel is the first therapeutic to be reviewed for Gleevec-resistant CML and ALL.

Ellen Berman, who served as a voting consultant to ODAC, said adverse effects associated with Sprycel -- particularly fluid retention and myelosuppression, which frequently require treatment interruptions and dose reductions -- make Sprycel "more complicated to give than imatinib." She added that the safety issues are manageable and that "it is clear that the risk-benefit is far in favor of benefit." Berman is an oncologist who treats leukemia patients at Memorial Sloan-Kettering Cancer Center. ...