Previously, AM0010 received the US 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.
“With Orphan designations in Europe and the United States, we are committed to accelerating AM0010’s development for this difficult-to-treat cancer, which unfortunately has the highest mortality rate of all major cancers,” said Peter Van Vlasselaer, Ph.D., president and chief executive officer of ARMO BioSciences. “We are motivated by the US and EU regulatory agencies’ recognition of the urgent need to develop new therapeutic options for pancreatic cancer patients and are eager to begin dosing the first patients in our pivotal Phase 3 clinical trial shortly.”
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.
ARMO BioSciences is a clinical-stage immuno-oncology company developing a pipeline of novel, proprietary medicines that activate a cancer patient’s own immune system to eradicate tumors.
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