EMA validates MAA for pemigatinib in patients with cholangiocarcinoma.- Incyte

Incyte announced the validation of the Company’s Marketing Authorization Application (MAA) for pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma ( bile duct cancer) with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. The MAA application is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma. Comment: Incyte announced in November 2019 that the FDA has accepted for Priority Review its New Drug Application (NDA) for pemigatinib, as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. The Prescription Drug User Fee Act (PDUFA) target action date is 30 May 2020.