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FDA grants orphan drug designation to varlitinib for cholangiocarcinoma
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The FDA granted orphan drug designation to varlitinib — an oral, novel pan-HER inhibitor — for the treatment of patients with cholangiocarcinoma, according to a press release from the drug’s manufacturer.
Ongoing phase 2 studies are evaluating varlitinib (ASLAN001; ASLAN Pharmaceuticals, Array BioPharma) in patients with cholangiocarcinoma — a rare and aggressive form of bile duct cancer — and breast cancer. Many of these studies of varlitinib are primarily conducted in Asia, where the incidence of cholangiocarcinoma is ten times higher than in western populations.
Researchers also are planning studies to evaluate varlitinib in patients with gastric cancer, according to the press release.
"In addition to our work in cholangiocarcinoma, we are progressing our portfolio of immunotherapies and targeted agents in other Asia-prevalent tumor types, including gastric cancer and hepatocellular carcinoma," Carl Firth, PhD, CEO of ASLAN Pharmaceuticals, said in a press release.
The FDA’s Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are 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.