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.
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