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  • SPRYCEL Patient Site
  • BMS Resources
  • Full Prescribing Information
  • Indications

    INDICATIONS

    SPRYCEL® (dasatinib) is indicated for the treatment of adult patients with:

    • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
    • Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
    • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy

    SPRYCEL® is indicated for the treatment of pediatric patients 1 year of age and older with:

    • Newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy
    • Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase

PUT PATIENTS ON A PATH TO SUCCESS

Early and sustained response across key efficacy endpoints1*

cCCyR rates vs imatinib by Year 1 and Year 51

  • Year 1 cCCyR: 77% (95% CI: 71%-82%) for SPRYCEL® (dasatinib) (n=259) vs 66% (95% CI: 60%-72%) for imatinib (n=260; P=0.007)1
  • Year 5 cCCyR: 83% for SPRYCEL (n=259) vs 79% for imatinib (n=260)1
Not an actual patient.

Dasatinib does not appear to be active against the T315I mutation, based on in vitro data.1

In newly diagnosed chronic phase CML patients:

  • Drug-related serious adverse reactions (SARs) were reported for 16.7% of SPRYCEL-treated patients. Serious adverse reactions reported in ≥5% of patients included pleural effusion (5%)
  • Most common adverse reactions (≥15%) included myelosuppression, fluid retention, and diarrhea

cCCyR=confirmed complete cytogenetic response; CI=confidence interval; MMR=major molecular response.

*Inclusive of cCCyR in newly diagnosed adult patients with CP Ph+ CML by 1 and 5 years.

Confirmed CCyR (cCCyR) was defined as CCyR (0% Ph+ metaphases) on 2 consecutive occasions at least 28 days apart.1,2

Adjusted for Hasford score and indicated statistical significance at a predefined nominal level of significance.1

||MMR (at any time) defined as BCR-ABL ratios of ≤0.1% by RQ-PCR in peripheral blood samples standardized on the International Scale. These are cumulative rates representing minimum follow-up for the time frame specified.1

References:

  1. SPRYCEL full Prescribing Information. Bristol-Myers Squibb Company.
  2. Kantarjian H, Shah NP, Hochhaus A, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010;362(24):2260-2270.