Published On: Tue, Dec 3rd, 2019

Incyte secures FDA priority review for pemigatinib in cholangiocarcinoma

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Delaware-based pharma company has secured priority review for pemigatinib from the US Food and Drug Administration (FDA) for the of locally advanced or metastatic cholangiocarcinoma.

The priority review for pemigatinib is for the treatment of the condition in previously treated having FGFR2 fusions or rearrangements.

Cholangiocarcinoma is a rare cancer that occurs in the bile duct. The FDA gives priority review to that could provide a major advance in treatment where currently there are no options. The designation reduces the review period to eight months from the 12- month waiting period under a standard review.

The Prescription Drug User Fee Act (PDUFA) action date for pemigatinib is 30 May 2020.

Incyte secures FDA priority review for pemigatinib in cholangiocarcinoma

Incyte secures FDA priority review for pemigatinib in cholangiocarcinoma. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

The investigational drug is a selective fibroblast growth factor receptor (FGFR) inhibitor.

The new drug application (NDA) submission of the FGFR inhibitor, which has been accepted by the FDA, is based on the results of the phase 2 FIGHT-202 study.

The mid-stage study assessed the drug as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma.

Results from the trial showed that in patients harboring FGFR2 fusions or rearrangements, the FGFR inhibitor as monotherapy showed an overall response rate (ORR) of 36% to meet the primary endpoint. The median progression-free survival (PFS) was 6.9 months, which met the secondary endpoint, with a median follow-up of 15 months.

In preclinical studies, pemigatinibis said to have shown selective pharmacologic activity against cancer cells with FGFR alterations that were discovered and developed by Incyte. The FDA gave the drug breakthrough therapy designation for the treatment of previously treated, advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma.

Peter Langmuir – Group Vice President of Incyte Targeted Therapeutics 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. 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.”

About a year ago, Incyte entered into a deal worth up to $391.5 million with Chinese biopharma company Innovent Biologics for three clinical-stage product candidates discovered and developed by the latter, which included pemigatinib, – a JAK1 inhibitor and parsaclisib – a PI3Kδ inhibitor.

As per the terms of the agreement, Innovent Biologics had been given the rights to develop and commercialize the three assets in hematology and oncology in Mainland China, Hong Kong, Taiwan, and Macau. Investigational New Drug (IND) approvals for all the three drug candidates were given in November 2019 by China’s National Medical Products Administration ().

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