NEW YORK – The National Institute for Health and Care Excellence (NICE) in the UK said on Thursday it granted conditional marketing authorization to pemigatinib (Incyte's Pemazyre) for previously treated patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement.
The recommendation was based on data from the Phase II FIGHT-202 trial. That study included one cohort of patients with cholangiocarcinoma, or bile duct cancer, with FGFR2 fusions or rearrangements. In the cohort, patients treated with pemigatinib had a median progression-free survival of 6.9 months and median overall survival of 21.1 months. However, that study did not compare pemigatinib to the currently used treatment, modified folinic acid, 5-fluorouracil and oxaliplatin (mFOLFOX) chemotherapy, the current treatment in the UK.
In an earlier appraisal, NICE did not recommend the treatment because it did not meet the cost-effectiveness threshold to be a good use of National Health Service (NHS) resources. However, Incyte then provided further data from FIGHT-202 to address uncertainties identified by NICE.
The list price for pemigatinib is £7,159.04 ($9,797) for a pack of 14 13.5-mg tablets. Based on that list price, the annual cost of pemigatinib is £124,430 ($170,289). Incyte has offered pemigatinib to the NHS at a confidential discount.
NICE estimated that 50 bile duct cancer patients annually would be eligible for treatment with pemigatinib. The institute said that data suggests pemigatinib is more effective than current treatments, but noted that the data is limited because this type of cancer is rare.
Pemigatinib is already approved in the US and EU for the same indication. In Japan, pemigatinib was approved for patients with FGFR2 fusion-positive unresectable biliary tract cancer that has progressed after chemotherapy. In the US, pemigatinib was approved alongside Foundation Medicine's FoundationOne CDx as a companion test to identify this subset of patients.