Glofitamab monotherapy [GLO1]

For the treatment of previously treated adult patients with diffuse large B-cell lymphoma who have received 2 or more lines of systemic therapy where the following criteria have been met:

  1. I confirm that this application is being made by and the first cycle of systemic anti-cancer therapy with glofitamab monotherapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. I confirm that 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 glofitamab. 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. I confirm that 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. I confirm below 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 glofitamab. 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. I confirm below whether the patient has been previously treated with stem cell transplantation:
  • No previous stem cell transplantation OR
  • Yes, previous stem cell transplantation
  1. I confirm below 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. I confirm that the patient has not been previously treated with glofitamab unless either glofitamab monotherapy needs to be continued following EAMS access/a Roche compassionate access scheme or the patient received and responded to no more than 3 cycles of glofitamab monotherapy used specifically as bridging treatment prior to 3rd or more line of CAR T therapy. Note: glofitamab 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 glofitamab OR
  • continuation of previous treatment with glofitamab monotherapy via EAMS and all other criteria on this form are fulfilled OR
  • continuation of previous treatment with glofitamab monotherapy via a Roche compassionate access scheme and all other criteria on this form are fulfilled OR
  • previous treatment with no more than 3 cycles of glofitamab monotherapy specifically used as bridging therapy prior to 3rd or more line CAR T therapy and the patient responded to this glofitamab bridging therapy
  1. I confirm that the patient has not received any treatment with a bispecific antibody targeting both CD20 and CD3 other than glofitamab as specified above in criterion 7. Note: use of glofitamab after previous treatment with epcoritamab is NOT commissioned.
  2. I confirm that the patient has an ECOG performance status score of 0 or 1.
  3. I confirm that I am aware that a single dose of obinutuzumab 1000mg monotherapy is to be given on cycle 1 day 1 to mitigate the risk of cytokine release syndrome.
  4. I confirm that with the exception of the single dose of obinutuzumab in cycle 1, glofitamab is to administered as monotherapy and not in combination with any other systemic therapies for lymphoma.
  5. I understand that I am aware that the dosing schedule of glofitamab in cycle 1 is 2.5mg on day 8 and 10mg on day 15, increasing to 30mg per cycle from cycle 2 day 1 onwards.
  6. I confirm that treatment with glofitamab monotherapy will be stopped at whichever of the following events occurs first: disease progression or unacceptable toxicity or withdrawal of patient consent or after a maximum of twelve 3-weekly cycles of glofitamab. Note: once glofitamab is stopped after 12 cycles of treatment, it cannot be re-started.
  7. I confirm that I and the treating team are familiar with the grading of cytokine release 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.
  8. I confirm that I and the treating team are aware that the patient must be admitted overnight for at least the cycle 1 day 8 administration of glofitamab and potentially for further glofitamab infusions if grade 2 or greater cytokine release syndrome occurs with the previous glofitamab infusion.
  9. I confirm that 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.
  10. I confirm that a formal medical review as to whether treatment with glofitamab should continue or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
  11. I confirm that when a treatment break of more than 6 weeks beyond the expected 3-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
  12. I confirm that glofitamab will be otherwise used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 16 November 2023

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA927 (17 October 2023)

Current Form Version

Note

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.

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.

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