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Incyte claims FDA priority review for bile duct cancer drug

Significant need for new therapies in hard-to-treat cancer type


Incyte’s new drug pemigatinib has been given a priority review for a rare type of bile duct cancer by the FDA, setting up an approval decision by 30 May.

Fibroblast growth factor receptor (FGFR) inhibitor pemigatinib is under review by the US regulator for patients with previously treated, locally advanced or metastatic cholangiocarcinoma whose tumours have FGFR2 mutations.

The filing is based on the results of the FIGHT-202 study in these patients, recently presented at the ESMO congress, which showed an overall response rate of 36% in patients treated with pemigatinib, with a median response duration of 7.5 months.

Cholangiocarcinoma patients who have relapsed after first- or second-line therapy typically live for between six and 10 months, so claiming even a few months before disease progression could be clinically very significant.

“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, Incyte’s head of targeted therapeutics.

“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,” he added.

Pemigatinib is one of a handful of new targeted drugs coming through development for bile duct cancer that it is hoped could provide a step forward in treatment for the hard-to-treat cancer.

Other FGFR inhibitors being tested for bile duct cancer include Johnson & Johnson’s Balversa (erdafitinib) – approved earlier this year for FGFR-mutated bladder cancer – as well as Bridge Bio’s infigratinib.

Meanwhile, Agios’ IDH1 inhibitor Tibsovo (ivosidenib), which is already approved as a treatment for acute myelogenous leukaemia (AML), has also shown promise in trials for cholangiocarcinoma.

Along with a priority review, pemigatinib has been awarded breakthrough status by the FDA for FGFR-mutated cholangiocarcinoma. Incyte says cholangiocarcinoma affects between 0.3 – 3.4 people per 100,000 in North America and Europe, and 10-16% if cases involve FGFR mutations.

Pemigatinib is also in phase 2 testing for bladder cancer and myeloid/lymphoid cancers.

Article by
Phil Taylor

28th November 2019

From: Regulatory



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