INCY - Incyte's pemigatinib gets positive recommendation from CHMP
Incyte ([[INCY]] -1.9%) announces that the European Medicines Agency's ((EMA)) Committee for Medicinal Products for Human Use ((CHMP)) has issued a positive recommendation for its marketing application of pemigatinib for the treatment of certain adults with a form of unresectable locally advanced or metastatic cholangiocarcinoma.The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.If approved, pemigatinib will be the first targeted treatment in the EU for the indication, and would be commercialized under the brand name Pemazyre.The European Commission usually backs the CHMP's recommendation for approval, but is not obligated to do so.
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Incyte's pemigatinib gets positive recommendation from CHMP