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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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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
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