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  • SPRYCEL Patient Site
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  • 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

Clinical trial results for adults with imatinib-resistant or
-intolerant Ph+ CML in CP

Study design1,2
  • Phase III, randomized, open-label, international, multicenter, dose-optimization trial of CP Ph+ CML adult patients (N=670) resistant or intolerant to imatinib randomized to one of four dosing schedules:
    • SPRYCEL® (dasatinib) 100 mg once daily (n=167), SPRYCEL 140 mg once daily (n=167), SPRYCEL 50 mg twice daily (n=168), SPRYCEL 70 mg twice daily (n=168)
  • The median duration of treatment was 22 months
  • The primary endpoint in chronic phase Ph+ CML was major cytogenetic response (MCyR). MCyR combines both complete (0% Ph+ metaphases) and partial (>0%–35%) responses
  • Secondary endpoints included rates of MCyR in imatinib-intolerant patients, rates of complete hematological response (CHR), time to and duration of MCyR and CHR, progression-free survival (PFS), overall survival, and safety evaluations
  • Efficacy
  • Transformation Rates
SPRYCEL is the only TKI for imatinib-resistant or -intolerant CP Ph+ CML with 7-year efficacy data in the PI1
Response rates for CP Ph+CML patients resistant or intolerant to imatinib taking SPYCEL 100 mg once daily (n=167) at a minimum follow-up of 2 yearsResponse rates for CP Ph+CML patients resistant or intolerant to imatinib taking SPYCEL 100 mg once daily (n=167) at a minimum follow-up of 2 years

MMR was achieved in 44% (n=73/167) of patients taking SPRYCEL 100 mg once daily within 7 years1

  • Dasatinib does not appear to be active against the T315I mutation, based on in vitro data1
Based on data 7 years after the last patient was enrolled in the trial1:
  • 44% of patients were known to be alive
  • 25% of patients had an unknown survival status and 31% of patients were known to have died
SELECTED IMPORTANT SAFETY INFORMATION
  • In adult patients resistant or intolerant to prior imatinib therapy:
    • Drug-related SARs were reported for 26.1% of SPRYCEL-treated patients treated at the recommended dose of 100 mg once daily in the randomized dose-optimization trial of patients with chronic phase CML resistant or intolerant to prior imatinib therapy. Serious adverse reactions reported in ≥5% of patients included pleural effusion (10%)
    • The most common adverse reactions (≥15%) included myelosuppression, fluid retention events, headache, diarrhea, fatigue, dyspnea, musculoskeletal pain, nausea, hemorrhage and skin rash
    • Grade 3/4 hematologic laboratory abnormalities in chronic phase CML patients resistant or intolerant to prior imatinib therapy who received SPRYCEL 100 mg once daily with a minimum follow up of 60 months included neutropenia (36%), thrombocytopenia (24%), and anemia (13%). Other grade 3/4 laboratory abnormalities included: hypophosphatemia (10%), and hypokalemia (2%)
Low transformation rate with SPRYCEL 100 mg once daily1
Graphic shows Philadelphia positive Chronic myeloid leukemia patients who transformed to Accelerated Phase (AP) or Blast Crisis (BC) while on the study by year 7. Ninety-five % of SPRYCEL-treated patients on study did not transform to AP or BC (158 out of 167). Dasatinib does not appear to be active against the T315I mutation, based on in vitro studies. Graphic shows Philadelphia positive Chronic myeloid leukemia patients who transformed to Accelerated Phase (AP) or Blast Crisis (BC) while on the study by year 7. Ninety-five % of SPRYCEL-treated patients on study did not transform to AP or BC (158 out of 167). Dasatinib does not appear to be active against the T315I mutation, based on in vitro studies.

In the trial, 95% (n=158/167) of patients treated with SPRYCEL 100 mg once daily did not transform to AP or BC1

  • Dasatinib does not appear to be active against the T315I mutation, based on in vitro studies1
SELECTED IMPORTANT SAFETY INFORMATION
  • In adult patients resistant or intolerant to prior imatinib therapy:
    • Drug-related SARs were reported for 26.1% of SPRYCEL-treated patients treated at the recommended dose of 100 mg once daily in the randomized dose-optimization trial of patients with chronic phase CML resistant or intolerant to prior imatinib therapy. Serious adverse reactions reported in ≥5% of patients included pleural effusion (10%)
    • The most common adverse reactions (≥15%) included myelosuppression, fluid retention events, headache, diarrhea, fatigue, dyspnea, musculoskeletal pain, nausea, hemorrhage and skin rash
    • Grade 3/4 hematologic laboratory abnormalities in chronic phase CML patients resistant or intolerant to prior imatinib therapy who received SPRYCEL 100 mg once daily with a minimum follow up of 60 months included neutropenia (36%), thrombocytopenia (24%), and anemia (13%). Other grade 3/4 laboratory abnormalities included: hypophosphatemia (10%), and hypokalemia (2%)

AP=accelerated phase; BC=blast crisis; CCyR=complete cytogenetic response; CHR=complete hematological response; MCyR=major cytogenetic response; MMR=major molecular response; PI=Prescribing Information; TKI=tyrosine kinase inhibitor; ULN=upper limit of normal; WBC=white blood cell.

*Resistance to imatinib was defined as failure to achieve a complete hematologic response (CHR; after 3 months), major cytogenetic response (MCyR; after 6 months), or complete cytogenetic response (CCyR; after 12 months); or loss of a previous molecular response (with concurrent ≥10% increase in Ph+ metaphases), cytogenetic response, or hematologic response.

Imatinib intolerance was defined as inability to tolerate 400 mg or more of imatinib per day or discontinuation of imatinib because of toxicity.

MCyR combines both complete (0% Ph+ metaphases) and partial (>0%–35%) responses.1

§CHR (response confirmed after 4 weeks): WBC ≤ institutional ULN, platelets <450,000/mm3, no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <20%, and no extramedullary involvement.1

CCyR=0% Ph+ metaphases.1

See safety results for newly diagnosed patients

References:

  1. SPRYCEL full Prescribing Information. Bristol-Myers Squibb Company.
  2. Shah NP, Kantarjian HM, Kim D-W, et al. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008;26(19):3204-3212.