1676 – Amendments to eligibility criteria for tisagenlecleucel for treatment of relapsed or refractory diffuse large B-cell lymphoma – amend clinical criteria for patients with Transformed Follicular Lymphoma (TFL) and propose inclusion of patients with grade 3B follicular lymphoma (3B FL)

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type -
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Supported

Application details

Reason for application

Minor changes to the MSAC eligibility criteria are requested:

  • to allow TFL patients who have undergone prior autologous stem cell transplant (ASCT) to access tisagenlecleucel, without the requirement for additional systemic therapy post-ASCT; and
  • that grade 3B FL patients be considered as DLBCL in the eligibility criteria due to the similarity of grade 3B FL to DLBCL in terms of presentation, behaviour and outcomes.

Service or technology in this application

Tisagenlecleucel is an autologous, murine anti-CD19 Chimeric Antigen Receptor T cell (CAR-T) therapeutic process, involving harvesting, modifying, expanding and re-infusing a patient's own immune T-cells, to target and destroy certain cancerous cells.

Type: Hybrid health technology

Medical condition this application addresses

Diffuse Large B-Cell Lymphoma (DLBCL) is an aggressive and common subtype of Non-Hodgkin Lymphoma (NHL).

Previous applications

Application documents

Public summary document

We aim to provide documents in an accessible format. If you're having problems using a document with your accessibility tools, please contact us for help.

Meetings to consider this application

  • PASC meeting: Expedited – Bypassing PASC
  • ESC meeting: Expedited – Bypassing ESC
  • MSAC meeting: 29 to 30 July 2021