ASLAN Pharma Receives Second FDA Orphan Drug Designation For VARLITINIB (ASLAN001)
ASLAN Pharmaceuticals announced the designation as an Orphan drug of its pan-HER inhibitor varlitinib (ASLAN001) by the US Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for gastric cancer. Varlitinib previously received Orphan Drug Designation for cholangiocarcinoma in August 2015.
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Gastric cancer is an aggressive form of cancer that is most often diagnosed when it is already in its advanced stage. Prognosis for the disease remains poor despite it being the third leading cause of cancer deaths globally.
The FDA awards Orphan Drug Designation to advance the evaluation and development of drugs and products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. The OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products. Orphan Drug Designation will provide ASLAN certain incentives including extended marketing exclusivity to develop varlitinib in gastric cancer.
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ASLAN is currently conducting phase 2 studies of varlitinib in gastric cancer, cholangiocarcinoma and breast cancer.