B-MS' Sprycel approved for resistant CML

USA-based pharmaceutical firm Bristol-Myers Squibb says that the European Commission has approved Sprycel (dasatinib; formerly known as BMS-354825) for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukemia (CML) who have demonstrated resistance or intolerance to prior therapy. The firm explained that the agent is able to inhibit a wider range of mutation subtypes of the Bcr-Abl protein, which is over-expressed in CML, than the current standard therapy, imatinib mesylate.

The company said that the decision expands on the agent's approved indications, which includes its use in the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia, as well as in lymphoid blast CML with resistance or intolerance to therapy.

The European Medicines Agency's (EMEA) approval decision is based on data from five Phase II multicenter studies of the drug in CML and Ph+ ALL patients who were resistant or intolerant to imatinib mesylate. The results indicated that the agent demonstrated significant hematological and cytogenetic efficacy, and had brought about durable responses in those treated.