Pemigatinib [PEMIG1]

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 pemigatinib is being made by and the first cycle of systemic anti-cancer therapy with pemigatinib 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 or
• the cholangiocarcinoma is of extrahepatic origin

3. 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.
4. The patient has unresectable locally advanced or metastatic disease.
5. 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 or
• the patient has been previously treated with ≥2 lines of systemic therapy for cholangiocarcinoma

6. The patient has not previously received any specifically FGFR2-targeted therapy unless futibatinib 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 Or
• futibatinib 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

7. The patient has an ECOG performance status of 0 or 1 or 2.
8. 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 pemigatinib.
9. Pemigatinib will be used as monotherapy.
10. The patient will be treated until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner.
11. The prescribing clinician understands that pemigatinib can cause serous retinal detachment and therefore opthalmological examination (including optical coherence tomography) has been arranged prior to initiation of pemigatinib and then whilst on therapy (every 2 months for the first 6 months and every 3 months thereafter).
12. The prescribing clinician is aware of the risk of the patient developing hyper-phosphataemia during treatment with pemigatinib and understand all of the following: the requirement for monitoring of phosphate levels, the role of phosphate-lowering measures and the to review such measures if pemigatinib treatment is deferred or discontinued. need drug interactions 13. The prescribing clinician is aware of the important which can occur between pemigatinib and CYP3A/P-gp inhibitors and inducers as outlined in sections 4.2 and 4.5 of the pemigatinib SPC.
13. The prescribing clinician is aware that the use of proton pump inhibitors should be avoided in patients receiving pemigatinib.
14. A first formal medical review as to whether treatment with pemigatinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
15. When a treatment break of more than 6 weeks beyond the expected 3-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment.
16. Pemigatinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 24 September 2021

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA722 (25 August 2021)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

Older Form Versions

There are previous versions of this form. These may not all be available on this site.

• PEMIG1_prior_to_cdf_1.355
• PEMIG1_prior_to_cdf_1.361