Investigational Compound ABT-414 Receives Orphan Drug Designation for Glioblastoma Multiforme
The U.S. Food and Drug Administration has granted orphan drug designation to AbbVie’s investigational compound ABT-414, which is being evaluated for safety and efficacy in patients with glioblastoma multiforme.
ABT-414 is an investigational anti-EGFR (epidermal growth factor receptor) monoclonal antibody drug conjugate being evaluated for the treatment of patients with various cancer and tumor types. The agent is designed to be stable in the bloodstream and only release the potent cytotoxic agent once inside targeted cancer cells.
Results from the phase I clinical trial evaluating ABT-414 in patients with recurrent or unresectable glioblastoma multiforme were presented at the 2014 ASCO Annual Meeting in Chicago earlier this year.
The orphan drug designation is a status assigned to a medicine intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States or that are not expected to recover the costs of developing and marketing a treatment.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
