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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  12/21/2018
 
Trade Name:  Sprycel
 
Generic Name or Proper Name (*):  dasatinib
 
Indications Studied:  Pediatric patients one year and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy
 
Label Changes Summary:  *Safety and effectiveness of Sprycel in combination with chemotherapy have been demonstrated in pediatric patients one year and over with newly diagnosed Ph+ ALL. *Use in pediatric patients is supported by evidence from one pediatric study. There are no data in children under 1 year. *The safety profile in pediatric patients was comparable to that reported in studies in adults. *Monitor bone growth and development in pediatric patients. *Five patients with Ph+ ALL 2 to 10 years of age received at least one dose of SPRYCEL tablet dispersed in juice. The exposure for dispersed tablets was 36% lower as compared to intact tablets in pediatric patients. Due to the limited available clinical data, it is unclear whether dispersing Sprycel tablets significantly alters the safety and/or efficacy of Sprycel. *New indication.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Bristol-Myers Squibb Company
 
Pediatric Exclusivity Granted Date:  09/27/2018
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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