ARMO BioSciences’ Immunotherapy AM0010 Receives Orphan Drug and Fast Track Designations from the
U.S. FDA for the Treatment of Pancreatic Cancer
Redwood City, CA, November 14, 2016 — ARMO BioSciences, Inc., a clinical-stage biotechnology company, announced that the U.S. Food and Drug Administration (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 Agency 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
“Orphan Drug and Fast Track designations represent key achievements for ARMO as we execute our plans to advance AM0010 into our first
About Fast Track Designation
The U.S. FDA’s Fast Track is a designation for expedited review to facilitate the development of drugs for the treatment of serious or life-threatening conditions which address an unmet medical need.
About Orphan Drug Designation
The U.S. FDA’s Office of Orphan Products Development (OOPD) provides incentives for sponsors to develop products for rare diseases. The Agency’s Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for development incentives, including marketing exclusivity in the U.S. for seven years after product approval, tax credits, and exemption from the prescription drug user fee.
About Pancreatic Cancer
According to the American Cancer Society’s recent estimates, approximately 53,000 people will be diagnosed and approximately 41,800 people will die from this form of cancer in the United States in 2016. Pancreatic cancer accounts for only three percent of all cancer cases in the United States, but is attributed to approximately seven percent of all cancer deaths.
Cancer of the pancreas usually develops without early symptoms. As a result, more than half of patients are diagnosed at a late stage, when one- and five-year survival is only 15% and 2%, respectively.
AM0010 is a PEGylated form of recombinant human
About ARMO BioSciences
Founded in 2012, ARMO BioSciences is a clinical-stage company developing immunotherapies focused on multiple difficult-to-treat oncology indications. The company’s lead immunotherapy AM0010, a PEGylated form of recombinant human
For more information, please visit www.armobio.com.
ARMO BioSciences, Inc.
Scott Ogg, PhD
Vice President Corporate Development and Operations