Health Canada Drug Update - SPRYCEL (dasatinib)

Health Canada has issue a Notice of Compliance under the Notice of Compliance with Conditions (NOC/c) policy for SPRYCEL(dasatinib) tablets in the treatment of adults with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

This NOC/c is based on the results of an open-label, multicenter, international (Europe, South America and Asia-Pacific regions), randomized, Phase 3 study (CA180056) conducted in adult patients with newly diagnosed chronic phase CML. Patients were randomized to receive either SPRYCEL 100 milligram (mg) once daily or imatinib 400 mg once daily. The primary endpoint was the rate of confirmed complete cytogenetic response (cCCyR) within 12 months. Secondary endpoints included time-in cCCyR (measure of durability of response), time-to cCCyR, major molecular response (MMR) rate, time-to MMR, progression free survival (PFS), and overall survival (OS). The secondary endpoints will be evaluated after a minimum of 5-year follow up.

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