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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:  05/17/2017
 
Trade Name:  Jevtana
 
Generic Name or Proper Name (*):  cabazitaxel
 
Indications Studied:  Solid tumors
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients have not been established. *Jevtana was evaluated in 39 pediatric patients (ages 3 to 18 years) receiving prophylactic granulocyte - colony stimulating factor. No objective responses were observed in 11 patients with refractory high grade glioma or diffuse intrinsic pontine glioma. One patient had a partial response among the 9 patients with ependymoma. *Infusion-related/hypersensitivity reactions were seen in 10 patients (26%). Three patients experienced serious adverse events of anaphylactic reaction. The incidence of infusion related/hypersensitivity reactions decreased with steroid premedication. *The most frequent treatment-emergent adverse events were similar to those reported in adults. *Information on safety, dosing, PK parameters, and clinical trials.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Sanofi Aventis
 
Pediatric Exclusivity Granted Date:  05/18/2017
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
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