Pemigatinib accepted for FDA priority review for cholangiocarcinoma

The US Food and Drug Administration has accepted for Priority Review the New Drug Application (NDA) for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for patients with previously treated, locally-advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.

The NDA submission by US biotech0 Incyte (Nasdaq: INCY) is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally-advanced or metastatic cholangiocarcinoma. Study results, recently presented at the European Society for Medical Oncology (ESMO) 2019 Congress, demonstrated that in patients harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 36% (primary endpoint), and median duration of response (DOR) of 7.5 months (secondary endpoint) with a median follow-up of 15 months. Adverse events were manageable and consistent with the mechanism of action of pemigatinib.

“There is a significant need for new therapies for patients with cholangiocarcinoma, who have limited treatment options beyond first-line chemotherapy and often face a poor prognosis,” said Dr Peter Langmuir, group vice president, targeted therapeutics, Incyte.