FDA nod for Pemazyre for metastatic cholangiocarcinoma

US biotechnology firm Incyte’s (Nasdaq: INCY) shares advanced 4.5% to $100.00 by close of trading on Friday, as it revealed that the US Food and Drug Administration has approved Pemazyre (pemigatinib), ahead of the Prescription Drug User Fee Act (PDUFA) target date of May 30, 2020.

Pemazyre, a kinase inhibitor, is approved 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.

Pemazyre is the first and only FDA-approved treatment for this indication, which was cleared under accelerated approval based on overall response rate and duration of response (DOR). Continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial(s). The drug was submitted for European approval in January this year.