Erdafitinib [ERD1]

Erdafitinib for unresectable locally advanced or metastatic urothelial carcinoma which has a susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alteration in patients previously treated with at least one line of therapy containing a PD-1 or PD-L1 inhibitor administered in the unresectable locally advanced or metastatic treatment setting where the following criteria have been met:

1. This application for erdafitinib is being made by and the first cycle of systemic anti-cancer therapy with erdafitinib will be prescribed by a consultant specialist specifically trained accredited in the use of systemic anti-cancer therapy.
2. The patient is an adult with a histologically or cytologically confirmed diagnosis of urothelial carcinoma. Please also indicate below whether the urothelial carcinoma is of upper tract or lower tract origin:

• the urothelial carcinoma is of upper tract origin Or
• the urothelial carcinoma is of lower tract origin

3. The urothelial carcinoma has been tested for FGFR3 genomic alterations and at least 1 of the following FGFR3 genetic alterations has been determined with a validated test and result is positive: an FGFR3 gene mutation (R248C or S249C or G370C or Y373C) or a FGFR gene fusion (FGFR3-TACC3 or FGFR3- BAIAP2L1). Please also indicate below which genetic alteration is positive:

• one of these FGFR3 gene mutations: R248C or S249C or G370C or Y373C Or
• one of these FGFR3 gene fusions: FGFR3-TACC3 or FGFR3- BAIAP2L1 Or
• both a FGFR3 mutation and a FGFR3 fusion are positive

4. The patient has unresectable locally advanced or metastatic disease.
5. The patient has been previously treated with at least 1 line of systemic therapy containing a PD-1 or PD-L1 inhibitor given in the unresectable locally advanced or metastatic treatment setting. Note: neoadjuvant or adjuvant therapy containing a PD-1 or PD-L1 inhibitor with disease progression during or within 12 months of its completion counts as treatment in the advanced/metastatic disease setting.
6. The patient has an ECOG performance status of 0 or 1 or 2.
7. 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 erdafitinib.
8. The patient has not previously received any specifically FGFR3-targeted therapy unless the patient has received erdafitinib via a company early access scheme and the patient meets all the criteria set out on this form.
9. Erdafitinib 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 erdafitinib can cause serious ocular toxicity and therefore formal opthalmological examinations are to be arranged prior to initiation of erdafitinib, monthly for the first 4 months of treatment, 3-monthly from then on and otherwise urgently as required. Note: the baseline opthalmological examination should include an Amsler grid test, fundoscopy, visual acuity and if available optical coherence tomography. The monitoring opthalmological examinations should at least include an Amsler grid test.
12. The prescribing clinician is aware of the need for erdafitinib dose modifications and interruptions according to the development of hyper-phosphataemia and eye, nail, skin or mucosal adverse events related to erdafitinib as outlined in the erdafitinib SPC
13. The prescribing clinician is aware of the important drug interactions which can occur between erdafitinib and CYP2C9 and CYP3A4 inhibitors and CYP3A4 inducers as well as other clinically significant interactions as outlined in section 4.5 of the erdafitinib SPC.
14. A first formal medical review as to whether treatment with erdafitinib 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 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment
16. Erdafitinib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

CDF funded From: 10 April 2025

Additional information

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CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

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The data on this page was produced using version 1.358 of the CDF list, downloaded from an archive of NHS England’s website on 10 April 2025 at 14:00.

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.

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