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:  08/15/2019
 
Trade Name:  Rozlytrek
 
Generic Name or Proper Name (*):  entrectinib
 
Indications Studied:  Treatment of adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion with a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity
 
Product Labeling:  *Safety and effectiveness in pediatric patients aged 12 years and older with solid tumors that have an NTRK gene fusion have been established. *The effectiveness in adolescent patients was established based on extrapolation of data from three open-label, single-arm clinical trials in adult patients with solid tumors harboring an NTRK gene fusion (ALKA, STARTRK-1, and STARTRK-2) and pharmacokinetic data in adolescents enrolled in STARTRK-NG. *Safety in pediatric patients 12 years and older was established based on extrapolation of data in adults and data from 30 pediatric patients enrolled in STARTRK-NG. *Due to the small number of pediatric and adult patients, it is not possible to determine whether the observed differences in the incidence of adverse reactions to Rozlytrek are related to patient age or other factors. In an expanded safety database that included 338 adult patients and 30 pediatric patients who received Rozlytrek across clinical trials, the Grade 3 or 4 adverse reactions and laboratory abnormalities that occurred more frequently in pediatric patients (n = 30) compared with adults (n = 338) were neutropenia (27% vs 2%), bone fractures (23% vs 5%), increased weight (20% vs 7%), thrombocytopenia (10% vs 0.3%), lymphopenia (7% vs 1%), increased gamma-glutamyl transferase (7% vs 0%), and device-related infection (7% vs 0.3%). *Safety and effectiveness in pediatric patients less than 12 years with solid tumors who have an NTRK gene fusion have not been established. *Safety and effectiveness in pediatric patients with ROS1-positive NSCLC have not been established. *Information on dosing, PK parameters, adverse reactions including drug-drug interactions, lab abnormalities, and clinical trial. *New drug.  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Genentech
 
NNPS:  FALSE
 
Therapeutic Category:  Antineoplastic
 
-
-