Biopharmaceutical company Incyte has announced that the US Food and Drug Administration (FDA) accepted for priority review its New Drug Application (NDA) for pemigatinib as a treatment for patients with cholangiocarcinoma
is cancer that forms in the bile duct
, with patients often diagnosed at a late or advanced stage.
The drug Pemigatinib
is a selective fibroblast growth factor receptor (FGFR) inhibitor with the potential to treat patients with previously managed, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements.
Pharma giant Incyte has submitted the NDA based on data from the FIGHT-202 study that evaluated pemigatinib
as a treatment for cholangiocarcinoma
In the FIGHT-202 Phase II study, patients enrolled into Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF / FGFR genetic alterations) or Cohort C (no FGF / FGFR genetic alterations).
The recent FIGHT-202 Phase II, open-label, multicentre study evaluates the safety and efficacy of pemigatinib
in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma
with documented FGF / FGFR status.
Bile duct cancer
patients were administered 13.5mg pemigatinib
orally once daily (QD) on a 21-day cycle until radiological disease progression or unacceptable toxicity.
The main primary endpoint of FIGHT-202 is the overall response rate (ORR) in Cohort A. Secondary endpoints include ORR in Cohorts B, A plus B, and C, as well as progression-free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety across cohorts.
FGFRs are said to play an essential role in tumour cell proliferation and survival, migration and angiogenesis.
The drug, Pemigatinib
is a potent inhibitor of FGFR isoforms 1, 2 and 3, which has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations
Study results showed that in patients with FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy yielded an overall response rate (ORR) of 36% (primary endpoint). Furthermore, pemigatinib
also resulted in a median duration of response (DOR) of 7.5 months (secondary endpoint) with a median follow-up of 15 months.
The pharma company told Thailand Medical
News that adverse events were manageable and consistent with pemigatinib
The Fibroblast Growth factor receptor in oncology and Haematology Trials (FIGHT) clinical trial programme includes ongoing Phase II and III studies investigating the safety and efficacy of pemigatinib
therapy across FGFR-driven malignancies.
The US FDA also granted pemigatinib
Orphan Drug designation for the treatment of cholangiocarcinoma