Neogenix Oncology has received approval from the US Food and Drug Administration (FDA) for ensituximab, a monoclonal antibody, for the treatment of pancreatic cancer.
Neogenix had initiated a Phase I clinical trial of ensituximab in December 2009, for the treatment of advanced pancreatic and colorectal cancer.
The orphan drug designation provides Neogenix with seven years of market exclusivity for ensituximab for the treatment of pancreatic cancer upon regulatory approval.
The orphan drug designation is granted by the FDA to those drugs that address an unmet clinical need, which treat diseases affecting more than 200,000 people in the US.
Pancreatic cancer is the fourth leading cause of cancer-related death in the US, and about 43,000 people in the US are affected by this disease every year.