New Label Recommends Lower Starting Dose for BMS Cancer Drug

The FDA has approved new labeling for Bristol-Myers Squibb’s (BMS) leukemia drug Sprycel recommending a lower starting dose of 100 mg once daily.

The lower dose reduces side effects while preserving the efficacy of Sprycel (dasatinib) for patients with chronic-phase chronic myeloid leukemia (CML) who no longer respond to other therapies.

The new label includes safety and efficacy data for a greater number of patients with chronic-phase CML who were resistant or intolerant to prior therapy, including Novartis’ Gleevec (imatinib mesylate). Also included are data from the first randomized trial of Sprycel and Gleevec.