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Incyte's Pemazyre Approved in Japan for Biliary Tract Cancer With FGFR2 Fusions

NEW YORK – The Japanese Ministry of Health, Labor, and Welfare (MHLW) has approved Incyte's FGFR inhibitor pemigatinib (Pemazyre) for patients with FGFR2 fusion-positive unresectable biliary tract cancer that has progressed after chemotherapy.

FGFR2 fusions show up primarily in intrahepatic cholangiocarcinoma, a subtype of biliary tract cancer, and occur rarely in Japanese patients with these tumors. MHLW granted orphan drug status to pemigatinib given the rarity of this biomarker-defined tumor type.

Japanese regulators approved the drug based on results of the FIGHT-202 trial of pemigatinib in patients with previously treated, locally advanced or metastatic cholangiocarcinoma. In the cohort of patients with FGFR2 fusion-positive tumors, 36 percent of those on pemigatinib responded to the treatment and their duration of response was 7.49 months. 

The US Food and Drug Administration approved the drug in this setting based on the same data a year ago, and the European Medicines Agency's Committee for Medicinal Products for Human Use recommended conditional marketing authorization last month.