Sprycel

Sprycel (dasatinib) is approved for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy, and pediatric patients with Ph+ CML in chronic phase. The initial approval date was November 9, 2017, with a supplemental New Drug Application approval for pediatric patients on May 9, 2017. The applicant is Bristol-Myers Squibb Company.

In clinical studies, Sprycel demonstrated efficacy with a cumulative Major Cytogenetic Response (MCyR) rate of 98% and a cumulative Complete Cytogenetic Response (CCyR) rate of 96.1%. The cumulative Major Molecular Response (MMR) rate was 88.2%. For safety, Grade 3 or 4 thrombocytopenia occurred in 63% of patients. Grade 3 or 4 fluid retention was observed in 5% of newly diagnosed chronic phase CML adults and 6% in newly diagnosed or imatinib-resistant or -intolerant chronic phase CML adults. Cardiac ischemic events were reported in 3.9% of dasatinib-treated patients compared to 1.6% in imatinib-treated patients.