The U.S. Food and Drug Administration (FDA) has accepted Priority Review its New Drug Application (NDA) for Incyte’s pemigatinib as a treatment for a type of a rare type of bile duct cancer.
“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 Peter Langmuir, M.D., group vice president, Targeted Therapeutics, Incyte. “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. We intend to work closely with the FDA to bring this innovative targeted therapy to patients suffering from this devastating disease as soon as possible.”
The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period to eight months compared to 12 months for Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date is May 30, 2020.
Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor.The incidence of cholangiocarcinoma varies regionally and ranges between 0.3 – 3.4 per 100,000 in North America and Europe.
Incyte is based near Wilmington and is working to build a drug pipeline beyond its blockbuster drug Jakafi.
For more information about clinical trials, visit https://clinicaltrials.gov/ct2/show/NCT02924376.