FDA Grants Brain Tumor Drug Rare Pediatric Disease Designation


ABT-414 receives designation for the treatment of diffuse intrinsic pontine glioma (DIPG).

The FDA granted Rare Pediatric Disease Designation to ABT-414 for the treatment of pediatric patients with diffuse intrinsic pontine glioma (DIPG).

ABT-414 is an investigational monoclonal antibody drug conjugate that targets the epidermal growth factor receptor (EGFR). The approval was based on a proposed pediatric sub-study within the ongoing phase 2 study of ABT-414 in adults with recurrent EGFR-amplified glioblastoma.

The study was 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,” said Gary Gordon, MD, vice president of oncology clinical development at AbbVie. “This Rare Pediatric Disease 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.”

DIPG are highly aggressive brain tumors found at the base of the brain, accounting for approximately 10 to 15% of all pediatric brain tumors.

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