The regulator’s decision was based on a proposed pediatric sub-study nested within the ongoing phase 2 trial of ABT-414 in adults with recurrent epidermal growth factor receptor (EGFR)-amplified glioblastoma.
ABT-414 targets the EGFR developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals and Seattle Genetics.
The drug conjugate is being assessed by AbbVie to treat adult patients with EGFR-amplified glioblastoma, a malignant primary brain tumor.
In 2014, ABT-414 secured orphan drug designation the FDA and the European Medicines Agency to treat glioblastoma and glioma in adults, respectively.
Earlier this year, the FDA granted rare disease designation to ABT-414 for the treatment of pediatric patients with EGFR-amplified DIPG.
The efficacy and safety of ABT-414 have not been established by the FDA or any other health authority, AbbVie said.
AbbVie vice president of oncology clinical development Gary Gordon said: "Pediatric patients with high grade gliomas have a rare and fatal disease. This Rare Pediatric Designation, a first for AbbVie, is an important advancement as we continue to evaluate ABT-414 and its potential to help this group of patients who desperately need a new treatment option.
"The proposal of including a nested cohort within an adult global trial is an endeavor that we hope may bring more treatments to pediatric patients."
Image: AbbVie US Headquarters. Photo: courtesy of AbbVie Inc.