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EMA Committee Recommends Approval for Incyte's Pemazyre in Bile Duct Cancer

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended conditional marketing authorization for pemigatinib (Incyte's Pemazyre) in previously treated, locally advanced, or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement.

The recommendation is based on data from the Phase II FIGHT-202 trial, which enrolled 146 patients in three cohorts: patients with FGFR2 fusions or rearrangements, patients with other types of FGF or FGFR genetic alterations, and patients with no FGF or FGFR genetic alterations.

The trial enrolled 107 patients with previously treated, locally advanced, or metastatic cholangiocarcinoma who had FGFR2 fusions or rearrangements. The objective response rate in this group was 36 percent, with three patients achieving a complete response after treatment with pemigatinib.

The European Commission will now consider CHMP's recommendation in deciding whether to approve the drug in this setting. If approved, pemigatinib will be the first targeted treatment in the EU for this indication.

Last year, the US Food and Drug Administration approved this same indication for pemigatinib alongside Roche subsidiary Foundation Medicine's FoundationOne CDx as a companion test to identify patients with FGFR rearrangements.

"The positive CHMP opinion is a crucial milestone for patients with cholangiocarcinoma, who often have very limited treatment options due to the difficulty of identifying patients during the early disease stages," Peter Langmuir, group VP of oncology targeted therapeutics at Incyte, said in a statement. "Following the recent FDA approval of pemigatinib, we are delighted to be closer to offering the first targeted therapy in Europe to benefit these patients."

Incyte is also conducting a Phase III study, FIGHT-302, evaluating pemigatinib plus chemotherapy as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

The company is also studying pemigatinib in bladder cancer with FGFR3 fusions or rearrangements, myeloproliferative neoplasms with FGFR1 fusions or rearrangements, and solid tumors with FGFR mutations.