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Abbvie announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG), known to be highly aggressive and difficult to treat brain tumors found at the base of the brain.
DIPG is the most common subtype of tumor in this anatomical region and the second most common malignant brain tumor of childhood, with an estimated 200-400 children affected each year in the United States.
The FDA granted the Rare Pediatric Disease Designation based on a proposed pediatric sub-study "nested" within the ongoing Phase 2 study of ABT-414 in adults with recurrent EGFR-amplified glioblastoma, conducted in collaboration with the European Organization for Research and Treatment of Cancer (EORTC).
"Pediatric patients with high grade gliomas have a rare and fatal disease.2 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," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. "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."
ABT-414 is an investigational monoclonal antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR) developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics.
AbbVie is evaluating it for the treatment of adult patients with EGFR-amplified glioblastoma, an aggressive malignant primary brain tumor. In 2016, the FDA granted Rare Disease Designation to ABT-414 for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Gliomas (DIPG). ABT-414 is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.
