US FDA approves pemigatinib for treatment of patients with cholangiocarcinoma

Approval was based on a RCT (n=107) in which patients received pemigatinib once a day for 14 days, followed by 7 days off, in 21-day cycles until the disease progressed or the patient experienced an unreasonable level of side effects.

SPS commentary:

Pemigatinib is an inhibitor of fibroblast growth factor receptor (isoforms 1 2 and 3). A marketing authorisation application has also been filed with the European Medicines Agency.


US Food and Drug Administration