Published

May 16, 2026

Pembrolizumab [PEMB35]

Neo-adjuvant followed by adjuvant pembrolizumab for stage III macroscopic resectable melanoma in people 12 years and over where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with pembrolizumab will be prescribed by an oncologist and surgeon specifically trained and accredited in the use of systemic anti-cancer therapy with experience in the treatment of melanoma and immunotherapy.
  2. The patient has a confirmed histological diagnosis of malignant melanoma Please indicate whether the melanoma is BRAF V600 mutation positive or not:
  • Option 1: BRAF V600 mutation positive or
  • Option 2: BRAF V600 mutation negative or
  • Option 3: BRAF mutation testing was not possible as pathologist has document that there is insufficient tissue for BRAF mutation analysis
  1. The patient is aged 12 years or older.
  2. The patient meets all of the following criteria: Histologically confirmed cutaneous, acral or mucosal melanoma AND Macroscopic, resectable stage IIIB, C or D melanoma AND No previous treatment with any of the following treatments: anti-programmed death (PD-1), anti-programmed death ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibodies. AND Complete surgical resection of the tumour and therapeutic lymph node dissection is planned within 3 to 5 weeks of the last dose of neoadjuvant pembrolizumab and adjuvant pembrolizumab is expected to start within 3 months of surgery AND An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. The patient does not meet any of the exclusion criteria as specified in the NHS England Clinical Commissioning Policy.
  4. Stopping criteria as outlined in the Clinical Commissioning Policy has been explained and agreed with the patient before the treatment is started.
  5. The patient will receive the licensed dose and frequency of pembrolizumab as specified in the NHS England Commissioning Policy.
  6. The patient will be monitored in line with the NHS England Clinical Commissioning policy.
  7. When a treatment break of more than 12 weeks beyond the expected 6-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment, which MUST be approved before treatment is recommenced.
  8. Pembrolizumab will be otherwise used as set out in its Summary of Product of Characteristics
  9. The Trust policy regarding the use of unlicensed (off-label) treatments has been followed as these drugs in treatment are not licensed in this indication.

NHS funded From: 28 April 2026

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: NHSE Policy: URN2426 (NA)

Current Form Version

Note

The data on this page was produced using version 1.397 of the CDF list, downloaded from NHS England’s website on 15 May 2026 at 18:00.

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.

Older Form Versions

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

Citation

BibTeX citation:
@misc{untitled,
  author = {},
  title = {\textless\textless\textless FULL
    {TITLE\textgreater\textgreater\textgreater{}}},
  number = {\textless\textless\textless FORM
    ID\textgreater\textgreater\textgreater{}},
  date = {},
  url = {https://updates.chemo.org.uk/CDF_Forms/PEMB35.html},
  langid = {en}
}
For attribution, please cite this work as:
<<<FULL TITLE>>>. Chemotherapy Updates. https://updates.chemo.org.uk/CDF_Forms/PEMB35.html