The US Food and Drug Administration (FDA) has accepted Incyte’s new drug application (NDA) for the priority review of its pemigatinib to treat patients with cholangiocarcinoma.
The NDA has been accepted for the priority review of selective fibroblast growth factor receptor (FGFR) inhibitor pemigatinib to treat patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.
Incyte has submitted the application based on data from the FIGHT-202 study, which assessed pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma.
According to the company, the trial results showed that in patients harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 36%, which is the primary endpoint.
The trial also showed that median duration of response (DOR) of 7.5 months, a secondary endpoint, with a median follow-up of 15 months.
Cholangiocarcinoma, rare cancer that forms in the bile duct, is classified based on its origin. The intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver, while the extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver.
The FIGHT (fibroblast growth factor receptor in oncology and hematology Trials) clinical trial programme is comprised of ongoing phase 2 and 3 studies assessing safety and efficacy of pemigatinib therapy across various FGFR-driven malignancies.
Incyte already secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for pemigatinib to treat previously treated, advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma.
Incyte targeted therapeutics group vice president Dr Peter Langmuir said: “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.
“We are very pleased that the FDA has accepted our NDA for Priority Review which we believe represents an important step toward providing the first treatment option for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.”
In June 2018, the FDA approved a lower dose of Olumiant (baricitinib), a daily once oral Janus kinase (JAK) inhibitor developed by Lilly and Incyte to treat moderately-to-severely active rheumatoid arthritis (RA).