FDA Grants Priority Review to Pemigatinib for FGFR2+ Cholangiocarcinoma

November 27, 2019 – The FDA has granted a priority review to a 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 designation is based on interim findings from the multicohort, single-arm, phase II FIGHT-202 study, which showed that, at a median follow-up of 15 months, single-agent pemigatinib led to a 36% objective response … (leggi tutto)