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INDICATIONS
SPRYCEL® (dasatinib) is indicated for the treatment of adult patients with:
SPRYCEL® is indicated for the treatment of pediatric patients 1 year of age and older with:
The combined analysis included:
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).