Posted by Michael Wonder on 16 Nov 2016
ARMO BioSciences’ immunotherapy AM0010 receives orphan drug and fast track designations from the U.S. FDA for the treatment of pancreatic cancer
14 November 2016 - ARMO BioSciences announced that the U.S. FDA has granted the Company’s lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) orphan drug designation for the treatment of pancreatic cancer.
The FDA also granted fast track designation for AM0010 in combination with FOLFOX as a second-line therapy in patients with advanced metastatic pancreatic cancer. In an ongoing Phase 1 trial, over 340 patients with advanced solid malignancies have been dosed with AM0010, either as a single agent or in combination with standard-of-care chemotherapy drugs or anti-PD-1 antibodies. ARMO plans to initiate a pivotal Phase 3 trial by the end of 2016, using AM0010 in combination with FOLFOX as a second-line therapy in patients with advanced metastatic pancreatic cancer.
