AsianScientist (Jun. 28, 2016) – The pan-HER inhibitor varlitinib, which is being developed by Singapore-based biotech company ASLAN Pharmaceuticals, has received orphan drug designation by the US Food and Drug Administration (FDA) Office of Orphan Products Development for gastric cancer. Varlitinib previously received orphan drug designation for cholangiocarcinoma in August 2015.
Gastric cancer is an aggressive cancer that is most often diagnosed when it is already in advanced stages. Prognosis for the disease remains poor, despite it being the third leading cause of cancer deaths globally. Worldwide, gastric cancer has one of the highest incidence rates, with 952,000 new cases diagnosed in 2012.
In Asia, gastric cancer is the third most common cancer after breast and liver, and is the second most common cause of cancer deaths in Asia.
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.
ASLAN is currently conducting Phase II studies of varlitinib in gastric cancer, cholangiocarcinoma and breast cancer. Its portfolio of drugs include immunotherapies and targeted agents for tumor types prevalent in Asia.
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Source: ASLAN Pharmaceuticals.
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