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  • SPRYCEL Patient Site
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  • 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
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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
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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

Sprycel has been on the market for

Compare Year 1 and Year 5 MMR rates for SPRYCEL vs imatinib1
Convenient Once-Daily Dosing
Recommended dosing and
dose modifications
Safety and Management
See the AR profile
through Year 5
Resources for Patients
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Dasatinib (SPRYCEL) is a National Comprehensive Cancer Network® (NCCN®) Category 1 preferred treatment recommendation regardless of risk score.

NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

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.
  3. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myeloid Leukemia. V.1.2023. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed November 9, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.