INCY - Incyte's Pemazyre wins European Commission approval to treat rare form of cancer
Incyte ([[INCY]] -0.8%) announces that the European Commission ((EC)) has approved Pemazyre (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 ((FGFR2)) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.Cholangiocarcinoma is a rare cancer that forms in the bile duct, with the incidence of the condition ranging between 6,000 – 8,000 in Europe.The decision follows the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in January recommending the conditional marketing authorization of Pemazyre.The EC decision is based on data from the FIGHT-202 study evaluating the safety and efficacy of Pemazyre in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.The FIGHT-202 Phase 2, open-label, multicenter study is evaluating the safety and efficacy of Pemazyre – a selective fibroblast growth factor receptor inhibitor – in adult (age
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Incyte's Pemazyre wins European Commission approval to treat rare form of cancer