Epcoritamab monotherapy [EPC1]

For the treatment of previously treated adult patients with diffuse large B-cell lymphoma who have received 2 or more lines of systemic therapy which have included polatuzumab vedotin unless the use of polatuzumab vedotin was contraindicated where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with epcoritamab monotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti- cancer therapy.
  2. The patient has a histologically confirmed diagnosis of diffuse large B cell lymphoma (DLBCL) or transformed follicular lymphoma to DLBCL. The definition of DLBCL includes the following:
  • DLBCL not otherwise specified (NOS) [including germinal centre B-cell (GCB) and activated B-cell (ABC) subtypes]
  • primary mediastinal large B cell lymphoma
  • T cell rich B cell lymphoma
  • Epstein-Barr virus (EBV) positive DLBCL
  • intravascular large B cell lymphoma
  • double hit and triple hit high grade B cell lymphoma Note: Primary CNS lymphoma, Burkitt lymphoma and plasmablastic lymphoma are NOT included for treatment with epcoritamab. Please record in the box below whether the patient has DLBCL according to one of the above types of DLBCL or has transformed follicular lymphoma:
  • the patient has DLBCL according to one of the types within the above definition OR
  • the patient has transformed follicular lymphoma (TFL) to DLBCL
  1. The patient has DLBCL or TFL which has either relapsed following or is refractory to 2 or more lines of standard routinely commissioned systemic therapies and that within these 2 lines of therapy there has been treatment with an anti-CD20 regimen and an anthracycline-containing regimen. Note: patients with TFL must have received 2 or more lines of systemic therapy given specifically for the transformed follicular lymphoma.
  2. The patient has either previously received systemic therapy with a regimen containing polatuzumab vedotin or the use of a polatuzumab vedotin-containing regimen was contraindicated. Note: NICE preferred to assume equal efficacy between epcoritamab and polatuzumab plus bendamustine and rituximab (Pola-BR) and as treatment with epcoritamab was substantially more expensive than Pola-BR, NICE concluded that epcoritamab was not cost effective when compared with Pola-BR. Hence, epcoritamab was recommended by NICE for treating relapsed or refractory DLBCL in patients who have had 2 or more systemic therapies, but only if patients have received prior polatuzumab (whether relapsed following such treatment or refractory to it or if polatuzumab was not tolerated) or if treatment with polatuzumab was contraindicated. Please record in the box below which of the following applies to this patient:
  • previous treatment with 1st line polatuzumab vedotin-containing chemotherapy to which the patient had relapsed or refractory disease OR
  • previous treatment with 2nd or greater line polatuzumab vedotin-containing chemotherapy to which the patient had relapsed or refractory disease OR
  • previous treatment with a polatuzumab vedotin-containing chemotherapy which was not tolerated and hence treatment with polatuzumab vedotin was discontinued OR
  • the use of a polatuzumab vedotin-containing chemotherapy was contraindicated and hence the patient has not been treated with polatuzumab vedotin for this reason
  1. The number of lines of systemic therapy that the patient has received for the treatment of DLBCL. Note: induction chemotherapy prior to and then followed by stem cell transplantation counts as 1 line of systemic therapy. Similarly, bridging chemotherapy prior to and then followed by CAR T therapy counts as 1 line of systemic therapy. Note: patients who have had only 1 line of systemic therapy are not eligible for treatment with epcoritamab. Please record the number of lines of previous systemic therapy below:
  • 2 previous lines OR
  • 3 previous lines OR
  • 4 or more previous lines
  1. Whether the patient has been previously treated with stem cell transplantation:
  • No previous stem cell transplantation OR
  • Yes, previous stem cell transplantation
  1. Whether the patient has been previously treated with CAR T therapy and if so at which place in the treatment pathway:
  • No previous CAR T therapy OR
  • Yes, previous CAR T therapy as 2nd line therapy OR
  • Yes, previous CAR T therapy as 3rd or more line of therapy
  1. The patient has not been previously treated with epcoritamab unless either epcoritamab monotherapy needs to be continued following an Abbvie compassionate access scheme and all other treatment criteria on this form are fulfilled or the patient received and responded to no more than three 4-weekly cycles of epcoritamab monotherapy used specifically as bridging treatment prior to 3rd or more line of CAR T therapy. Note: epcoritamab cannot be used as bridging therapy for 2nd line CAR T therapy. Please record in the box below which of the following applies to this patient:
  • no previous treatment with epcoritamab OR
  • continuation of previous treatment with epcoritamab monotherapy via an Abbvie compassionate access scheme and all other criteria on this form are fulfilled OR
  • previous treatment with no more than 3 cycles of epcoritamab monotherapy specifically used as bridging therapy prior to 3rd or more line CAR T therapy and the patient responded to this epcoritamab bridging therapy
  1. The patient has not received any previous treatment with a bispecific antibody targeting both CD20 and CD3 other than epcoritamab as specified above in criterion 8. Note: use of epcoritamab after previous treatment with glofitamab is NOT commissioned.
  2. The patient has an ECOG performance status score of 0 or 1 or 2.
  3. Epcoritamab is to administered as monotherapy and not in combination with any other systemic therapies for lymphoma.
  4. The prescribing is aware that the planned dosing schedule of epcoritamab is in 4-weekly cycles and is as follows:
  • in cycle 1 is 0.16mg on day 1, 0.8mg on day 8 and 48mg on days 15 and 22
  • in cycles 2 and 3 is 48mg on days 1, 8, 15 and 22
  • in cycles 4 to 9 is 48mg on days 1 and 15
  • in cycle 10 and thereafter is 48mg on day 1 only.
  1. Treatment with epcoritamab monotherapy will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent. Note: there is no formal stopping rule for epcoritamab in this indication but once epcoritamab is electively stopped (ie not for reasons of toxicity), it cannot be re-started.
  2. The prescribing clinician and the treating team are familiar with the grading of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, its monitoring and management and the indications for use of tocilizumab and both I and the treating team have all undergone training in these clinical issues.
  3. The prescribing clinician and the treating team are aware that the patient must be admitted overnight for at least the cycle 1 day 15 administration of epcoritamab and potentially for further epcoritamab administrations if grade 2 or greater cytokine release syndrome occurs with the previous epcoritamab injection.
  4. 1 dose of tocilizumab is immediately available should tocilizumab be required for the treatment of cytokine release syndrome and access to an additional dose of tocilizumab within 8 hours of the previous tocilizumab must be ensured.
  5. A formal medical review as to whether treatment with epcoritamab should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment.
  6. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
  7. Epcoritamab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 04 June 2024

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CDF Managed Access: NA

NICE Technology Appraisal: TA954 (06 March 2024)

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The data on this page was produced using version 1.343 of the CDF list, downloaded from an archive of NHS England’s website on 26 January 2025 at 22:41.

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