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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:  06/29/2018
 
Trade Name:  Yondelis injection
 
Generic Name or Proper Name (*):  trabectedin
 
Indications Studied:  Pediatric histotypes of sarcoma
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients have not been established. *Safety (n=61) and efficacy (n=58) were assessed across five open-label studies in pediatric patients (aged 2 to less than 17 years) with pediatric histotypes of sarcoma. *No new safety signals were observed in pediatric patients across these studies. *Pharmacokinetic parameters in 17 pediatric patients (aged 3 to 17 years) were within the range of values previously observed in adults given the same dose per body surface area.
 
BPCA(B):  B
 
Sponsor:  Janssen
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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