Enfortumab vedotin in combination with pembrolizumab [ENF1]

For treatment of adult patients with untreated, metastatic urothelial cancer, when platinum-based suitable where the following criteria have

1. This application has been made by and the first cycle of systemic anti -cancer therapy with enfortumab vedotin & pembrolizumab will be/was prescribed by a consultant oncologist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The patient has a histologically- or cytologically confirmed diagnosis of unresectable or metastatic urothelial cancer (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Patients with squamous or sarcomatoid differentiation or mixed cell types are eligible.
3. In respect of his/her treatment for unresectable/advanced disease and at the time of starting enfortumab vedotin & pembrolizumab, the patient is/was treatment-naïve to systemic therapy
4. In the absence of enfortumab vedotin & pembrolizumab the patient would have been deemed eligible for treatment with cisplatin or carboplatin-based chemotherapy
5. The patient does not have ongoing sensory or motor neuropathy of grade 2 or higher
6. At the time of commencing pembrolizumab the patient has/had not received prior treatment with any of the following in respect of their urothelial cancer: anti-PD-1, anti-PD-L1, anti-PD-L2 and anti-CD137 treatments, unless these were given in a neo adjuvant and/or adjuvant setting and the most recent dose was given >12 months before recurrence was diagnosed
7. The patient has an ECOG performance status (PS) of 0, 1, or 2. Patients with a PS of 2 must have a haemoglobin of >10g/dl and a GFR >50ml/min or
8. The patient does not have active central nervous system metastases – if the patient does have such metastases these must be clinically stable, and the patient must not have chemotherapy is leptomeningeal disease met:
9. Enfortumab vedotin and pembrolizumab will be used in combination unless: • The patient experiences unacceptable toxicity that is attributable only to pembrolizumab, then they may continue enfortumab vedotin monotherapy until one of the criteria met • The patient experiences unacceptable toxicity that is attributable only to enfortumab vedotin, then they may continue pembrolizumab monotherapy until one of the criteria met
10. Treatment with enfortumab vedotin will be continued until disease progression, unacceptable toxicity, or withdrawal of patient consent, whichever of these events occurs first.
11. Treatment with pembrolizumab will be continued until disease progression, unacceptable toxicity, withdrawal of patient consent, or a maximum treatment duration of 35 cycles given 3-weekly, or its equivalent if 6-weekly dosing is used) whichever of these events occurs first.
12. When a treatment break of more than 12 weeks beyond the expected 3-weekly cycle length is needed, a treatment break form to restart treatment will be completed, which be approved before treatment is re-commenced.
13. Enfortumab vedotin and pembrolizumab will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs)

CDF funded From: NA

Additional information

Form version: 1.0

CDF Managed Access: No

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.372 of the CDF list, downloaded from NHS England’s website on 23 August 2025 at 23:36.

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.