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news.US-based biopharmaceutical firm AbbVie has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for its anti-epidermal growth factor receptor monoclonal antibody drug conjugate, ABT-414, to treat glioblastoma multiforme.
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Every year in the US and Europe, two to three out of every 100,000 people are diagnosed with glioblastoma multiforme, which has a five year survival rate of about 4%.
AbbVie oncology clinical development vice-president Gary Gordon said: "The orphan drug designation is an important regulatory advancement as we further our development in recurrent glioblastoma multiforme, a disease that is uniformly fatal with limited treatment options."
Currently, the company is evaluating the safety and efficacy of ABT-414 in Phase II trials in patients with glioblastoma multiforme based on the results of its Phase I program.
ABT-414 is an investigational anti-epidermal growth factor receptor (EGFR) monoclonal antibody drug conjugate (ADC) being assessed to treat patients with various cancer and tumor types.
As an ADC, ABT-414 is designed to be stable in the bloodstream and only release the potent cytotoxic agent once inside targeted cancer cells.
ABT-414 is developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals and Seattle Genetics.