New approved dasatinib regimen available for clinical use.
Dasatinib, a tyrosine kinase inhibitor of BCR-ABL, was originally approved for the second-line treatment of any-phase chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia at a dosage of 70 mg twice daily. In chronic-phase (CP) CML resistant to first-line imatinib, this regimen is more efficacious than high-dose imatinib. A Phase III study of CP CML has now shown that dasatinib 100 mg once daily is therapeutically noninferior to 70 mg twice daily and has an improved safety profile. Patients receiving dasatinib 100 mg once daily suffered significantly fewer thrombocytopenia (grade 3-4) and pleural effusion (all grades) events than those receiving dasatinib 70 mg twice daily. Fewer patients receiving dasatinib 100 mg once daily also required dose interruption/reduction or discontinuation. The recommended regimen for dasatinib in patients with CP disease and who are resistant or intolerant to primary therapy with imatinib is now 100 mg once daily.