Tebentafusp [TEB1]
Tebentafusp as monotherapy for adult patients with human leukocyte antigen HLA- A*02:01 positive unresectable or metastatic uveal melanoma where the following criteria have been met:
- This application for tebentafusp monotherapy is both being made by and the first cycle of systemic anti-cancer therapy with tebentafusp will be prescribed by a consultant melanoma specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- The patient is an adult with a histologically proven diagnosis of uveal melanoma.
- The patient’s uveal melanoma has been tested for human leukocyte antigen (HLA) and the result is positive for the subtype HLA-A*02:01.
- The patient has unresectable or metastatic uveal melanoma.
- The patient does not have symptomatic or untreated brain metastases.
- The patient has either been previously treated with any prior systemic therapy or not including if the patient has received tebentafusp via a company early access scheme and all other treatment criteria on this form apply. Please mark below which clinical scenario applies to this patient:
- the patient has not been treated with any prior systemic therapy or tebentafusp
- the patient has been treated with prior checkpoint inhibitor systemic therapy and has not received prior tebentafusp
- the patient has been treated with prior tebentafusp via a company early access scheme and both continues to benefit from tebentafusp and all other treatment criteria on this form apply
- The patient has an ECOG performance score of 0 or 1.
- Tebentafusp will be used as monotherapy only. Note: tebentafusp is not to be used in combination with any other agent.
- The treating hospital has facilities (including those for resuscitation) to manage severe reactions to tebentafusp including cytokine release syndrome (CRS).
- The prescribing clinician and the treating team are aware of the risks and grading of cytokine release syndrome (CRS), its monitoring and management as illustrated in Table 1 of section 4.2 of the tebentafusp Summary of Product Characteristics and both I and the treating team have all undergone training in these clinical issues.
- Clear arrangements have been made for the patient to be monitored as an inpatient for signs and symptoms of toxicities including CRS for 16 hours after administration of the first 3 x weekly doses of tebentafusp.
- The prescribing clinician and the treating team are aware that if any grade 3 or 4 hypotension occurs during any of the first 3 infusions, the patient will be monitored every hour for the next 4 hours in an outpatient setting for the
- There is immediate access to treatment with tocilizumab if required to manage CRS.
- The patient will be treated with tebentafusp until there is clear evidence of progressive disease or the occurrence of excessive toxicity or the withdrawal of patient consent, whichever is the sooner.
- A formal medical review as to how tebentafusp is being tolerated and whether treatment with tebentafusp should continue or not will be scheduled to occur at least by the end of the first 4 weeks of treatment.
- When a treatment break of more than 6 weeks beyond the expected weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
- Tebentafusp will be otherwise used as set out in its Summary of Product Characteristics (SPC).
NHS funded From: 09 April 2025
Additional information
Current Form Version
Note
The data on this page was produced using version 1.360 of the CDF list, downloaded from an archive of NHS England’s website on 25 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.