Pembrolizumab [PEMB6]

The treatment of relapsed or refractory classical Hodgkin lymphoma in CHILDREN who are stem cell transplant-ineligible and have failed brentuximab vedotin 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 a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
2. The prescribing clinician is fully aware of the management of and the treatment modifications that may be required for immune-related adverse reactions due to anti-PD-L1 treatments including pneumonitis, colitis, nephritis, endocrinopathies, hepatitis and skin toxicities.
3. The patient is a CHILD aged 3 years and older and has histologically documented classical Hodgkin lymphoma. Note: there is a separate Blueteq form to be used for pembrolizumab in this indication in adults.
4. The patient has failed at least 2 lines of chemotherapy and also failed treatment with brentuximab vedotin.
5. The patient has not received stem cell transplantation of any kind.
6. The patient is currently ineligible for stem cell transplantation.
7. The patient is EITHER potentially a candidate for future stem cell transplantation or not. Please mark appropriately in one of the boxes below:

• The patient is a candidate for future stem cell transplantation if there is sufficient benefit of treatment with pembrolizumab or
• The patient is not a candidate for stem cell transplantation however good the response to pembrolizumab may be

8. The patient has an ECOG performance status (PS) of 0 or 1 or its equivalent Lansky score.
9. The patient has not received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
10. Pembrolizumab is being given as monotherapy and will commence at a dose of 2mg/kg bodyweight up to a maximum of 200mg in 3-weekly cycles of pembrolizumab monotherapy.
11. A formal medical review as to whether treatment with pembrolizumab should continue or not will be scheduled to occur at least by the end of the third cycle of treatment with 3-weekly administration of pembrolizumab.
12. The patient will be treated until stem cell transplantation occurs or loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment or completion of 2 years of treatment with pembrolizumab, whichever is the sooner.
13. The patient will receive a maximum treatment duration with pembrolizumab of 2 years (or 35 x 3-weekly cycles of pembrolizumab).
14. When a treatment break of more than 12 weeks beyond the expected 3-weekly cycle length is needed, a treatment break approval form to re-start treatment will be completed.
15. Pembrolizumab will otherwise be used as set out in its Summary of Product Characteristics (SPC).

NHS funded From: 30 July 2024

Additional information

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CDF Managed Access: NA

NICE Technology Appraisal: TA967 (01 May 2024)

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