The European Medicines Agency has accepted Incyte Corp.'s application seeking approval of pemigatinib to treat a rare type of cancer that forms in the bile duct.
Wilmington, Del.-based Incyte is seeking approval for pemigatinib to treat adults with cholangiocarcinoma that has spread to nearby tissues or to other parts of the body. Cholangiocarcinoma is a rare form of cancer that develops in the bile ducts that connect the liver to the gallbladder and small intestine.
Incyte's therapy is meant for patients with this type of cancer who have a certain gene mutation of the fibroblast growth factor receptor 2 gene and whose cancer is either treatment-resistant or has relapsed after at least one prior cancer therapy.
The company said the marketing authorization application is backed by data from a phase 2 study called Fight-202, which showed that 36% of patients with the gene mutation who received the drug showed a reduction in their tumor size.
The new drug application for pemigatinib was granted priority review for the same indication in the U.S. on Nov. 27, 2019. The U.S. Food and Drug Administration is expected to make a decision around May 30.