ARMO BioSciences, Inc., a clinical-stage immuno-oncology company, announced that the European Commission (EC) has granted the Company’s lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) Orphan designation for the treatment of pancreatic cancer. The EC’s approval follows a positive opinion in November 2016 from the European Medicine Agency’s (EMA) Committee for Orphan Medicinal Products.
Previously, AM0010 received the U.S. Food and Drug Administration’s (FDA) Orphan Drug and Fast Track designations for pancreatic cancer. ARMO plans to initiate enrollment of an international pivotal Phase 3 clinical trial, using AM0010 in combination with FOLFOX as second-line therapy in patients with advanced metastatic pancreatic cancer.
Orphan Designation in Europe
The EMA examines Orphan designation applications for candidates intended for the treatment of life-threatening or chronically-debilitating rare conditions with a prevalence of less than five in 10,000 in the European Union. Orphan designation provides a number of incentives including protocol assistance at a reduced fee, access to the centralized authorization procedure and market exclusivity for up to 10 years once the medicine is approved.