FDA Grants AbbVie Rare Pediatric Use Designation For Cancer TreatmentBy
The US Food and Drug Administration (FDA) has granted a rare pediatric disease designation for AbbVie's investigational cancer treatment, ABT-414. The product is an investigational monoclonal antibody drug conjugate that targets the epidermal growth factor receptor (EGFR) to treat pediatric patients with EGFR-amplified diffuse intrinsic pontine glioma (DIPG), known to be highly aggressive brain tumors that are difficult to treat. The FDA and the European Medicines Agency granted orphan drug status to the compound in 2014 for adult glioblastoma and glioma, respectively.
AbbVie developed ABT-414 with components in-licensed from Darien, Connecticut-based Life Sciences Pharmaceuticals and Seattle Genetics. AbbVie is also evaluating the compound for treatment of adult patients with EGFR-amplified glioblastoma, an aggressive malignant primate brain tumor.