The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted orphan drug designation to AbbVie’s investigational brain tumor drug.
The drug, ABT-414, is being evaluated for safety and efficacy in patients with glioblastoma multiforme, the most common and most aggressive type of malignant primary brain tumor.
“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. “We are pleased to continue developing ABT-414 in Phase II clinical trials in patients with glioblastoma multiforme based on the results of our Phase I program.”
Glioblastoma multiforme is the most common and most aggressive type of malignant primary brain tumor. Before diagnosis, most patients experience a serious symptom of glioblastoma multiforme, such as seizure. Most patients succumb to the disease about 15 months after being diagnosed, since no long-term treatments are currently available. Standard treatment for the disease is surgical resection, radiotherapy and concomitant adjunctive chemotherapy. Each 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 approximately four percent.
AbbVie’s ABT-414 is an investigational anti-epidermal growth factor receptor antibody drug conjugate (ADC) being evaluated for the treatment of patients with various cancer and tumor types. The drug is designed to be stable in the bloodstream and only release the potent cytotoxic agent once inside targeted cancer cells. In addition to glioblastoma multiforme, ABT-414 is in clinical trials for the treatment of patients with squamous cell tumors.
Results from a Phase I clinical program 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.
Source: AbbVie Inc.
Last updated: 8/4/14; 3:45pm EST