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FDA approves Incyte’s Pemazyre as first targeted drug for bile duct cancer

Company says drug to be launched “immediately”

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Incyte has claimed FDA approval for Pemazyre, a targeted treatment for cholangiocarcinoma, also known as bile duct cancer, that has a specific genetic mutation.

The US biotech said it will launch Pemazyre (pemigatinib) “immediately” after the approval of the drug for previously treated, locally advanced or metastatic cholangiocarcinoma that cannot be treated with surgery and has an FGFR2 fusion mutation or other genetic rearrangement.

Cholangiocarcinoma is a rare cancer of the bile ducts that occurs in approximately 8,000 patients in the US a year. Pemazyre is only suitable for a proportion of these as FGFR2 fusions and rearrangements occur in between 9% and 14% of all cases.

The drug was approved for use alongside a companion diagnostic developed by Roche unit Foundation Medicine that can be used to identify this subset of patients.

The approval is based on the results of the FIGHT-202 study in these patients, presented at last year’s ESMO congress, which showed an overall response rate of 36% in patients treated with pemigatinib and a median response duration of 9.1 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 significant.

“Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,” said Ghassan Abou-Alfa of Memorial Sloan Kettering Cancer Center, who was an investigator in the FIGHT-202 trial.

“It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high.”

Pemigatinib is a kinase inhibitor that inhibits the FGFR2 receptor, and is one of a handful of new targeted drugs coming through development for cholangiocarcinoma that it is hoped could provide a step forward in treatment for the hard-to-treat cancer.

Incyte has started enrolling patients in the phase 3 FIGHT-302 trial of Pemazyre versus chemotherapy as a first-line treatment for patients with metastatic or surgically unresectable cholangiocarcinoma and activating FGFR2 rearrangements. It is also in phase 2 testing for bladder cancer and myeloid/lymphoid cancers.

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

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.

Pemigatinib was granted a priority review and breakthrough status by the FDA for bile duct cancer.

Article by
Phil Taylor

20th April 2020

From: Research

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