FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

EU Grants Orphan Designation to ARMO BioSciences Immunotherapy for Pancreatic Cancer

Jan. 10, 2017
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The European Commission granted an orphan designation to ARMO BioSciences’ immunotherapy AM0010 (PEGylated interleukin-10) for the treatment of pancreatic cancer.

Last month, AM0010 received a positive opinion from the European Medicine Agency's Committee for Orphan Medicinal Products. AM0010 previously received Orphan Drug and Fast Track designations from the FDA.

ARMO plans to launch an international Phase III clinical trial, examining AM0010 in combination with FOLFOX chemotherapy as second-line treatment in patients with metastatic pancreatic cancer.

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