Published

May 11, 2025

Loncastuximab tesirine monotherapy [LON1]

For the further treatment of adult patients with diffuse large B-cell lymphoma or high grade B-cell lymphoma who have received previous treatment with 2 or more lines systemic therapy (which have included polatuzumab vedotin unless the use of polatuzumab vedotin was contra-indicated) and in addition are not candidates for any future CAR T cell therapy where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with loncastuximab tesirine 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 high grade B cell lymphoma 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
  • high grade B-cell lymphoma (double hit and triple hit high grade B cell lymphoma) Note: Patients with primary CNS lymphoma, Burkitt lymphoma and plasmablastic lymphoma are NOT eligible for treatment with loncastuximab tesirine. 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 to DLBCL:
  • 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 to DLBCL either of which has relapsed following or during 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 to DLBCL must have received 2 or more lines of systemic therapy given specifically for the transformed follicular lymphoma to DLBCL
  2. The number of lines of systemic therapy that the patient has received for the treatment of DLBCL or TFL to 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 cell therapy counts as 1 line of systemic therapy. Note: patients who have had only 1 line of systemic multi-agent therapy are NOT eligible for treatment with loncastuximab tesirine. 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. The patient has been previously treated with stem cell transplantation:
  • No previous stem cell transplantation OR
  • Yes, previous stem cell transplantation
  1. The patient has been previously treated with CAR T cell therapy and if so at which place in the treatment pathway: of
  • No previous CAR T cell therapy and the patient is unsuitable for CAR T cell therapy both now and in the future OR
  • Yes, previous CAR T cell therapy as 2nd line therapy OR
  • Yes, previous CAR T cell therapy as 3rd or more line of therapy Note: Swedish Orphan Biovitrum (the company that markets loncastuximab tesirine) did not make an evidence submission to NICE for consideration of the use of loncastuximab tesirine in patients who are suitable for or might become eligible for CAR T cell therapy. Note: loncastuximab tesirine must not be used as bridging therapy for CAR T cell therapy. Note: patients who have had previous CD19-directed CAR T cell therapy must be re-biopsied prior to consideration of treatment with loncastuximab tesirine to ensure that the lymphoma retains CD19 protein expression (unless such a biopsy is unsafe for the patient and the patient has progressive disease at previously known sites of active disease and the previous histology was DLBCL or HGBCL).
  1. 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: the NICE recommendation for access to loncastuximab tesirine stipulates that for treating relapsed or refractory DLBCL in patients who have had 2 or more systemic therapies, lonastuximab is only recommended 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 patient has not been previously treated with loncastuximab tesirine unless loncastuximab tesirine has been accessed via a company compassionate access scheme and all other treatment criteria on this form are fulfilled.
  2. The patient has an ECOG performance status score of 0 or 1 or 2.
  3. Loncastuximab tesirine is to be administered as monotherapy and not in combination with any other systemic therapies for lymphoma.
  4. The dosing schedule of loncastuximab tesirine differs in cycle 3 and beyond from that used in cycles 1 and 2.
  5. Treatment with loncastuximab tesirine 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 loncastuximab tesirine in this indication but once loncastuximab is electively stopped (ie not for reasons of toxicity), it cannot be re-started.
  6. The prescribing clinician and the treating team are familiar with the dose modifications and delays required for the management of adverse reactions to loncastuximab tesirine, both haematological and non-haematological (eg for oedema, effusions, cutaneous toxicity and abnormal liver function tests).
  7. A formal medical review as to whether treatment with loncastuximab tesirine 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, a treatment break approval form will be completed to restart treatment
  9. Loncastuximab tesirine will be otherwise used as set out in its Summary of Product Characteristics (SPC)

NHS funded From: 30 April 2024

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA947 (31 January 2024)

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.