Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  05/07/2019
 
Trade Name:  Sutent
 
Generic Name or Proper Name (*):  sunitinib malate
 
Indications Studied:  Refractory solid tumors
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients have not been established. *Safety and pharmacokinetics were assessed in an open-label study in pediatric patients 2 years to <17 years of age (n=29) with refractory solid tumors. In addition, efficacy, safety and pharmacokinetics was assessed in another open-label study in pediatric patients 2 years to <17 years (n=27) with high-grade glioma or ependymoma. *The maximum tolerated dose normalized for body surface area was lower in pediatric patients compared to adults. *Sunitinib was poorly tolerated in pediatric patients. *The effect on open tibial growth plates in pediatric patients who received Sutent has not been adequately studied. *Information on adverse reactions and clinical trials.
 
BPCA(B):  B
 
Sponsor:  C.P. Pharmaceuticals International C.V.
 
Pediatric Exclusivity Granted Date:  02/07/2019
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
-
-