Pemigatinib to treat cholangio carcinoma

May 9, 2020 0 By FM

The US FDA has approved pemigatinib (Pemazyre), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Pemigatinib is the first and only FDA-approved treatment for this indication, which was approved under accelerated approval based on overall response rate and duration of response (DOR). 

The FDA approval was based on data from the FIGHT-202 study, a multi-centre, open-label, single-arm study that evaluated Pemazyre as a treatment for adults with cholangiocarcinoma. 

In patients harbouring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate of 36% (primary endpoint), and median DOR of 9.1 months (secondary endpoint).