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European Commission Approves Incyte's Pemazyre for Rare Bile Duct Cancer

NEW YORK – Incyte on Monday said that the European Commission has approved pemigatinib (Pemazyre) for the treatment of FGFR2 fusion-positive, locally advanced, or metastatic cholangiocarcinoma patients who have progressed after systemic therapy.

The EC's decision is in line with the conditional marketing authorization recommendation issued last month by the European Medicines Agency's Committee for Medicinal Products for Human Use. In approving the drug, regulators considered data from the FIGHT-202 trial, in which 37 percent of advanced bile duct cancer patients with FGFR2 fusions responded to pemigatinib with a median duration of response of eight months. 

Cholangiocarcinoma is a rare form of bile duct cancer that occurs in 6,000 to 8,000 patients in Europe, and FGFR2 fusions occur in 10 percent to 16 percent of intrahepatic cholangiocarcinoma patients.

"[Pemazyre] is the first new treatment option to be made available to these patients in the EU in over a decade and has demonstrated a high rate of durable responses in a setting where historically there has been no effective standard of care," Incyte CEO Hervé Hoppenot said in a statement. "We now look forward to working with individual countries in Europe to ensure eligible patients can access this new treatment as soon as possible."

The US Food and Drug Administration approved pemigatinib for the same indication last year.