Published

March 24, 2025

Futibatinib [FUT1]

For the treatment of patients for locally advanced or metastatic cholangiocarcinoma which has a fibroblast growth factor receptor 2 gene fusion/rearrangement in patients with disease progression during or after previous systemic therapy where the following criteria have been met:

  1. This application for futibatinib is being made by and the first cycle of systemic anti-cancer therapy with futibatinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has a histologically or cytologically confirmed diagnosis of cholangiocarcinoma. Please also indicate below whether the cholangiocarcinoma is of intrahepatic or extrahepatic origin:
  • the cholangiocarcinoma is of intra-hepatic origin
  • the cholangiocarcinoma is of extrahepatic origin
  1. The cholangiocarcinoma has been tested for fibroblast growth factor receptor 2 (FGFR2) gene fusion or rearrangement with a validated test and the result is positive.
  2. The patient has unresectable locally advanced or metastatic disease.
  3. The patient has been previously treated with systemic therapy for cholangiocarcinoma and the disease has progressed during or after such therapy. Please also indicate whether the patient has received 1 or >=2 lines of systemic therapy:
  • the patient has been previously treated with 1 line of systemic therapy for cholangiocarcinoma
  • the patient has been previously treated with >=2 lines of systemic therapy for cholangiocarcinoma
  1. The patient has an ECOG performance status of 0 or 1.
  2. The patient either has no known brain metastases or if the patient has brain metastases, the patient is symptomatically stable prior to starting treatment with futibatinib.
  3. The patient has not previously received any specifically FGFR2-targeted therapy unless either the patient has received futibatinib via a company early access scheme and the patient meets all the criteria set out on this form or pemigatinib monotherapy has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of progressive disease. Please mark below which scenario applies to this patient:
  • the patient has not been previously treated with a FGFR2-targeted therapy
  • the patient has received futibatinib via a company early access scheme and the patient meets all the criteria set out on this form
  • pemigatinib monotherapy has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of progressive disease
  1. Futibatinib will be used as monotherapy.
  2. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner.
  3. The prescribing clinician understands that futibatinib can cause serous retinal detachment and therefore opthalmological examination has been arranged prior to initiation of futibatinib and at 6 weeks after initiation of treatment and from then on urgently as required.
  4. The prescribing clinician is aware of the risk of the patient developing hyper-phosphataemia during treatment with futibatinib and understand all of the following: the requirement for monitoring of phosphate levels, the need for dietary restriction to limit phosphate intake, the management of hyper-phosphataemia as outlined in the futibatinib SPC and the need to review such measures if futibatinib treatment is deferred or discontinued.
  5. The prescribing clinician is aware of the important drug interactions which can occur between futibatinib and CYP3A/P-gp inhibitors and inducers as outlined in sections 4.2 and 4.5 of the futibatinib SPC.
  6. A first formal medical review as to whether treatment with futibatinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  7. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment.
  8. Futibatinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 12 December 2024

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA1005 (11 September 2024)

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