FDA releases Sprycel documents

Discussion at Friday's meeting of FDA's Oncologic Drugs Advisory Committee is likely to focus on an appropriate starting dose for Sprycel dasatinib from Bristol-Myers (BMY). BMY is seeking accelerated approval for Sprycel to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) in patients with resistance or intolerance to prior therapy. Sprycel is the first therapeutic to be reviewed for Gleevec-resistant CML and ALL.

Based on data from one Phase I trial that did not determine a maximum tolerated dose and five Phase II trials in 565 patients, the agency said that a starting dose of 50 mg twice daily or lower may be appropriate in chronic phase disease. FDA also said its recommended dose may result in less frequent dose interruptions and dose reductions than BMY's recommended dose of 70 mg twice daily. ...