Incyte announced the validation of the Company’s Marketing Authorization Application (MAA) for pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.
“The EMA’s validation of Incyte’s Marketing Authorization Application opens the review process as we seek to bring the first targeted therapy to Europe for patients with cholangiocarcinoma,” said Peter Langmuir, M.D., Group Vice President, Targeted Therapeutics, Incyte. “The need for new therapies for cholangiocarcinoma was also recently recognized by the U.S. Food and Drug Administration’s acceptance, for Priority Review, of our New Drug Application for pemigatinib this past November. We are looking forward to continuing to work with regulatory authorities to bring this novel targeted therapy to eligible patients around the world.”
The MAA application is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma.
Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor. The incidence of cholangiocarcinoma varies regionally, but ranges between 0.4 – 1.8 per 100,000 in Europe. FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16 percent of patients.