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Dasatinib

A Review of its Use in the Treatment of Chronic Myeloid Leukaemia and Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia

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Abstract

Dasatinib (Sprycel®) is an orally administered small molecule inhibitor of multiple tyrosine kinases, including BCR-ABL and SRC family kinases, which is indicated for the treatment of adults with newly diagnosed chronic-phase chronic myeloid leukaemia (CML), CML (chronic-, accelerated-or blast-phase) with resistance or intolerance to prior therapy, including imatinib, or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy. Dasatinib is ≈325-fold more active than imatinib in inhibiting wild-type ABL kinase in vitro and is active against a wide variety of imatinib-resistant BCR-ABL mutants, except for T315I. This article reviews the efficacy and tolerability of dasatinib in the treatment of patients with newly diagnosed chronic-phase CML or imatinib-resistant or -intolerant CML or Ph+ ALL, as well as summarizing its pharmacological properties.

In clinical trials, oral dasatinib was effective in achieving major or complete cytogenetic responses in both newly diagnosed and imatinib-resistant or -intolerant chronic-phase CML. Dasatinib was likewise effective in achieving major or overall haematological responses in imatinib-resistant or -intolerant, accelerated-or blast-phase CML, or Ph+ ALL. Responses were rapidly achieved within 1–3 months and were durable over 1–5 years of follow-up. The majority of adverse events with dasatinib were of mild to moderate severity. Fluid retention (including pleural effusion) was the most common adverse event. Haematological abnormalities were common and cytopenias were the most common grade 3/4 adverse events. Dasatinib 100 mg administered once daily was as effective as dasatinib 70 mg administered twice daily, and was better tolerated, being associated with lower incidences of pleural effusion and grade 3/4 thrombocytopenia, in particular. Dasatinib was more effective than high-dose imatinib in the treatment of patients with imatinib-resistant chronic-phase CML and was more effective thanstandard dosages of imatinib, as well as being associated with less frequent fluid retention, in patients with newly diagnosed chronic-phase CML. Dasatinib was generally equally effective in patients with or without BCR-ABL mutations at baseline.

Therefore, oral dasatinib is a highly effective once-daily therapy for the first-line treatment of newly diagnosed patients with chronic-phase CML, as well as for the treatment of patients with imatinib-resistant or -intolerant chronic-and advanced-phase CML or Ph+ ALL.

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    Paul L. McCormack & Susan J. Keam

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Correspondence to Paul L. McCormack.

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Various sections of the manuscript reviewed by: S. Mustjoki, Hematology Research Unit, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland; E. Raffoux, Département d’Hématologie, Hôpital Saint-Louis, Paris, France; P. Rousselot, University Versailles Saint-Quentin-en-Yvelines Service d’Hématologie et d’Oncologie Hôpital Mignot, Le Chesnay, France; G. Saglio, Department of Clinical and Biological Sciences, University of Turin, Turin, Italy; S. Soverini, Department of Hematology & Oncological Sciences, “Lorenzo e Ariosto Seràgnoli” University of Bologna, Bologna, Italy.

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘dasatinib’ was identified by searching databases since 1996 (including MEDLINE and EMBASE and in-house AdisBase), bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer).

Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘dasatinib’ and (‘chronic myeloid leukaemia’ or ‘chronic myeloid leukemia’ or ‘leukemia myeloid chronic-phase’ or ‘acute lymphoblastic leukaemia’ or ‘acute lymphoblastic leukemia’ or ‘precursor cell lymphoblastic leukemia-lymphoma’). Searches were last updated 12 August 2011.

Selection: Studies in patients with chronic myeloid leukaemia or Philadelphia chromosome-positive acute lymphoblastic leukaemia who received dasatinib. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Dasatinib, chronic myeloid leukaemia, Philadelphia chromosome-positive acute lymphoblastic leukaemia, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.

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McCormack, P.L., Keam, S.J. Dasatinib. Drugs 71, 1771–1795 (2011). https://doi.org/10.2165/11207580-000000000-00000

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