AbbVie announced that FDA and EMA have granted orphan drug status to its investigational anti-epidermal growth factor receptor antibody drug conjugate, ABT-414, for the treatment of glioblastoma multiforme.
It is estimated that each year in the US and Europe, two to three of every 100,000 people are diagnosed with the glioblastoma multiforme. The disease is the most common and aggressive form of malignant primary brain tumor with a 4% survival rate of five years.
"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," said Gary Gordon, MD, vice president, oncology clinical development, AbbVie, in a press statement. "We are pleased to continue developing ABT-414 in Phase II trials in patients with glioblastoma multiforme based on the results of our Phase I program."
Results from the Phase I studies evaluating ABT-414 in patients with recurrent or unresectable glioblastoma multiforme were presented at the 50th American Society of Clinical Oncology (ASCO) meeting in Chicago earlier this year.