Published

May 11, 2025

Polatuzumab vedotin in combination with bendamustine and rituximab [POL1]

For previously treated patients with relapsed or refractory diffuse large B-cell lymphoma and who are not candidates haematopoietic stem cell transplantation where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with polatuzumab vedotin in combination with bendamustine and rituximab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient is either an adult (age >=18 years) or a post-pubescent child (age <18 years). Please mark below whether the patient is an adult or a post-pubescent child:
  • the patient is an adult OR
  • the patient is a post-pubescent child* *Please note the use of polatuzumab vedotin in combination with bendamustine and rituximab is unlicensed in under 18 year old patients so the Trust policy regarding the use of unlicensed medicines should be followed.
  1. The patient has a histologically confirmed diagnosis of diffuse large B cell lymphoma (DLBCL). This 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 polatuzumab.
  1. The patient has DLBCL which has either relapsed following or is refractory to standard routinely commissioned DLBCL chemotherapies. Please record in the box below which of the following best applies to this patient now:
  • has only received 1st line DLBCL chemotherapy (R-CHOP or similar), responded to it but has now relapsed OR
  • has only received 1st line DLBCL chemotherapy (R-CHOP or similar) and is refractory to it OR
  • has received 2nd (or greater) line of chemotherapy (e.g. R-ICE, R-IVE, R-IGEV, R-GDP, R-GDCarbo, R-ESHAP, R- DHAP or R-GemOx), responded to it but has now relapsed OR
  • has received 2nd (or greater) line of chemotherapy (e.g. R-ICE, R-IVE, R-IGEV, R-GDP, R-GDCarbo, R-ESHAP, R- DHAP or R-GemOx) and is either refractory to it or had insufficient response to merit consideration of stem cell transplantation (SCT) OR
  • has relapsed/refractory disease after a previous autologous SCT OR
  • has relapsed/refractory disease after a previous allogeneic SCT OR
  • has relapsed/refractory disease after a previous CAR-T therapy
  • has relapsed/refractory disease and the patient has been formally accepted by the National CAR-T cell Clinical Panel for CAR-T therapy and polatuzumab combination therapy is being used as bridging therapy before CAR-T treatment
  1. The patient is not a candidate for future haemopoietic stem cell transplantation either as set out in formal local/regional lymphoma network guidelines or after discussion at a lymphoma multidisciplinary meeting which incorporates SCT centre representation. Please record in the box below which of the following best applies to this patient: for
  • not a candidate for SCT on account of fitness OR
  • not a candidate for SCT on account of comorbidities OR
  • not a candidate for SCT on account of inadequate response to salvage chemotherapy OR
  • has relapsed after SCT Note: it is expected that patients with relapsed/refractory disease after standard chemotherapy and who are fit for SCT will proceed to standard salvage chemotherapy and consideration of SCT
  1. The patient has not been previously treated with polatuzumab vedotin or the patient has been previously treated with polatuzumab vedotin in which case the patient responded to polatuzumab vedotin as a bridging therapy to CAR- T cell therapy and has relapsed following CAR-T cell therapy or if continuing previous treatment with polatuzumab vedotin, this was either within the polatuzumab EAMS scheme and all other criteria in this form are fulfilled or within the Interim SACT treatment options allowed for polatuzumab as bridging therapy to CAR-T therapy during the Covid-19 pandemic and all other criteria in this form are fulfilled. Please record in the box below which of the following applies to this patient:
  • no previous treatment with polatuzumab vedotin OR
  • the patient received and responded to bridging treatment with polatuzumab prior to CAR-T therapy, received the CAR-T cell therapy and has relapsed following the CAR-T therapy OR
  • continuation of previous treatment with polatuzumab within the EAMS scheme for the use of the combination of polatuzumab, bendamustine and rituximab OR
  • continuation of previous treatment with polatuzumab within the interim SACT change options allowed for polatuzumab as bridging treatment prior to CAR-T therapy during the Covid-19 pandemic
  1. Treatment with polatuzumab vedotin will be used in combination only with bendamustine and the intravenous formulation of rituximab.
  2. Either the patient has not been previously treated with bendamustine for DLBCL or if the patient has been treated previously with bendamustine for DLBCL, this application is to continue a previous registration for the polatuzumab EAMS scheme or the interim polatuzumab Covid-19 access or the patient received bendamustine as part of combination treatment with polatuzumab for bridging therapy to CAR-T cell treatment or if treated with bendamustine outside either of these three options, then the response duration to that course of treatment with bendamustine for DLBCL exceeded 1 year.
  3. The patient has an ECOG performance status score of 0 or 1 or 2.
  4. The patient will be treated with a maximum of six 3-weekly cycles of polatuzumab vedotin in combination with bendamustine and rituximab.
  5. The prescribing clinician understands that the use of bendamustine in this DLBCL indication is unlicensed and that Trust policy regarding the use unlicensed treatments has been followed.
  6. The prescribing clinician is fully aware of the MHRA warning in July 2017 that increased mortality has been observed in recent clinical studies in off-label use of bendamustine and that patients need to be monitored for opportunistic infection and hepatitis B reactivation.
  7. A formal medical review as to whether treatment with polatuzumab in combination with bendamustine plus rituximab should continue or not will be scheduled to occur at least by the end of the first 6 weeks of treatment.
  8. When a treatment break of more than 6 weeks beyond the expected 3-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including as appropriate if the patient had an extended break on account of Covid-19.
  9. Polatuzumab vedotin, bendamustine and rituximab will otherwise be used as set out in their respective Summary of Product Characteristics SPCs).

NHS funded From: 23 October 2020

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA649 (23 September 2020)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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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