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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

SPRYCEL was evaluated in 97 pediatric patients with newly diagnosed or imatinib-resistant/
intolerant CP-CML in 2 studies

The combined analysis included:

Efficacy of SPRYCEL® (dasatinib) in pediatric patients with CP-CML: cumulative response over time by minimum follow-up period
Chart shows the range of duration of response was (2.5+ to 66.5+ months for CCyR), (1.4 to 66.5+ months for MCyR), and (5.4+ to 72.5+ months for subjects who achieved MMR by month 24 and 0.03+ to 72.5+ months for subjects who achieved MMR at any time), where ‘+’ indicates a censored observation.Chart shows the range of duration of response was (2.5+ to 66.5+ months for CCyR), (1.4 to 66.5+ months for MCyR), and (5.4+ to 72.5+ months for subjects who achieved MMR by month 24 and 0.03+ to 72.5+ months for subjects who achieved MMR at any time), where ‘+’ indicates a censored observation.

CI=confidence interval; CCyR=complete cytogenetic response; MCyR=major cytogenetic response; MMR=major molecular response.

*Patients from pediatric study of newly diagnosed CP-CML receiving oral tablet formulation.

Patients from pediatric studies of imatinib-resistant or -intolerant CP-CML receiving oral tablet formulation.

With a median follow-up of 4.5 years in newly diagnosed patients, the median durations of CCyR, MCyR, and MMR could not be estimated as more than half of the responding patients had not progressed at the time of data cut-off. Range of duration of response was (2.5+ to 66.5+ months for CCyR), (1.4 to 66.5+ months for MCyR), and (5.4+ to 72.5+ months for subjects who achieved MMR by month 24 and 0.03+ to 72.5+ months for subjects who achieved MMR at any time), where ‘+’ indicates a censored observation.

With a median follow-up of 5.2 years in imatinib-resistant or -intolerant patients, the median durations of CCyR, MCyR, and MMR could not be estimated as more than half the responding patients had not progressed at the time of data cut-off. Range of duration of response was (2.4 to 86.9+ months for CCyR), (2.4 to 86.9+ months for MCyR), and (2.6+ to 73.6+ months for MMR), where ‘+’ indicates a censored observation.

IMPORTANT SAFETY INFORMATION ABOUT ADVERSE REACTIONS

The safety data reflects exposure to SPRYCEL in 97 pediatric patients with chronic phase CML.

In two non-randomized trials in 97 pediatric patients with chronic phase CML (51 patients newly diagnosed and 46 patients resistant or intolerant to previous treatment with imatinib), the median duration of therapy was 51.1 months (range 1.9 to 99.6 months).

  • Among the 97 CML pediatric subjects, drug-related adverse reactions leading to discontinuation were reported in 1 patient (1%)
  • Drug-related serious adverse reactions were reported for 14.4% of pediatric patients
  • Adverse reactions associated with bone growth and development were reported in 5 (5.2%) of pediatric patients with chronic phase CML
  • The most common adverse reactions (≥15%) in pediatric patients included myelosuppression, headache, nausea, diarrhea, skin rash, pain in extremity, and abdominal pain
See safety results for pediatric patients