Published

May 11, 2025

Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone [POL2]

For people with previously untreated diffuse large B-cell lymphoma where the following criteria have been met:

  1. This application is being made by and also the first cycle of systemic anti-cancer therapy with polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone 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 over) 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 that the use of polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone is unlicensed in patients who are under 18 years old and so the Trust policy regarding the use of unlicensed medicines should be followed.
  1. The patient has a histologically confirmed diagnosis of CD20 positive diffuse large B cell lymphoma (DLBCL) or CD20 positive follicular lymphoma grade 3B. Please mark below which of the two options applies:
  • the patient has CD20 positive DLBCL (which includes the types listed below) OR
  • the patient has CD20 positive follicular lymphoma grade 3B and as polatuzumab is unlicensed in this subtype of lymphoma, I confirm that the Trust policy regarding the use of unlicensed medicines will be followed Types of DLBCL:
  • DLBCL not otherwise specified (NOS) [including germinal centre B-cell (GCB) and activated B-cell (ABC) subtypes]
  • 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
  • ALK positive large B cell lymphoma
  • HHV8 positive DLBCL
  • transformation of CLL to DLBCL (Richter’s transformation)
  • transformation of follicular lymphoma to DLBCL
  • transformation of marginal zone lymphoma to DLBCL
  • transformation of nodular lymphocyte predominant Hodgkin lymphoma to DLBCL
  • post transplant lymphoproliferative disorder of DLBCL type Note: Primary CNS lymphoma, primary cutaneous DLBCL, primary effusion lymphoma, primary mediastinal B cell lymphoma, Burkitt lymphoma and plasmablastic lymphoma are NOT included for treatment with this first line polatuzumab combination.
  1. The International Prognostic Index (IPI) score for this patient is between 2 and 5. Please record in the box below the IPI score for this patient:
  • 2
  • 3
  • 4
  • 5 The IPI scores 1 for each of the following: Ann Arbor stage III or IV; age >60 years; LDH >1 x ULN; ECOG PS of 2 or more; extranodal involvement at 2 or more sites. Note: the use of polatuzumab vedotin in patients with an IPI score of 1 is NOT allowed. This is because the NICE positive recommendation is only for patients with an IPI score of 2 or more.
  1. This patient does not have any known CNS involvement by the lymphoma.
  2. The patient has an ECOG performance status score of 0 or 1 or 2.
  3. The patient has DLBCL or follicular lymphoma grade 3b either of which is previously untreated with any anthracycline-containing combination chemotherapy.
  4. The patient has either not been previously treated with polatuzumab vedotin or the patient was treated with polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone as 1st line therapy for DLBCL via a company early access scheme 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
  • continuation of previous treatment with polatuzumab within the company early access scheme for the use of the combination of polatuzumab, rituximab, cyclophosphamide and prednisolone for the 1st line treatment of DLBCL and all other criteria in this form are fulfilled
  1. Treatment with polatuzumab vedotin will be used in combination only with rituximab, cyclophosphamide, doxorubicin and prednisolone and that the intent from the start of treatment is to use standard (‘full’) doses of all these agents.
  2. The patient will be treated with a maximum of six 3-weekly cycles of polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone.
  3. A formal medical review as to whether treatment with polatuzumab in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone should continue or not will be scheduled to occur at least by the end of the second cycle of treatment.
  4. 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.
  5. Polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin and prednisolone will otherwise be used as set out in their respective Summary of Product Characteristics (SPCs).

NHS funded From: 30 May 2023

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA874 (01 March 2023)

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.