Dasatinib - new option for chronic myeloid leukaemia

Bristol-Myers Squibb launches Sprycel (dasatinib), licensed for the treatment of chronic, accelerated or blast phase chronic myeloid leukaemia (CML) resistant or intolerant to prior therapy including imatinib, and; Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast chronic myeloid leukaemia resistant or intolerant to prior therapy.

PHARMACOLOGY
Dasatinib is a tyrosine kinase inhibitor. It works through inhibition of both the inactive and active conformations of the BCR-ABL gene that initiates the production of tyrosine kinase. Tyrosine kinase triggers uncontrolled cell growth and is responsible for the development of CML. Dasatinib also targets other protein signalling pathways that may play a role in the disease.

CLINICAL STUDIES
Dasatinib has been evaluated in a Phase I study, and in five Phase II multi-centre studies, in patients resistant or intolerant to imatinib in all phases of CML or Ph+ ALL.

In the Phase I study, haematologic and cytogenetic responses were observed in all phases of CML and in Ph+ ALL in the first 84 patients treated and followed for up to 19 months.1

In one of the four single-arm, multi-centre studies, 186 patients were enrolled who were resistant or intolerant to imatinib. Interim data showed that within the first six months of follow up, 90% of patients experienced a complete haemotologic response  and 45% achieved a major cytogenetic response  (33% of these complete responses).2

In the 911 patients receiving Sprycel in clinical trials, the most common non-haematological adverse effects were gastrointestinal distress, fluid retention, headache and fatigue.

1. Talpaz M, Shah N, Kantarjian, H et al. Dasatinib in Imatinib-Resistant Philadelphia Chromosome-Positive Leukemias.  N Engl J Med 2006; 354: 2531-2541.
2. Dasatinib. Drugs R D 2006: 7 (2): 129-132.

Further information: BMS 01895 523000

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