Applications

1653 – Amendment to eligibility criteria for tisagenlecleucel for treatment of relapsed or refractory diffuse large B-cell lymphoma - removal of the requirement for patients to be “CD19-positive”

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 New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Not supported

Application details

Reason for application

Request to amend the eligibility criteria to remove the requirement for patients to be “CD19-positive”.

Service or technology in this application

Tisagenlecleucel is an autologous, murine anti-CD19 Chimeric Antigen Receptor T cell 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 is an aggressive and common subtype of Non-Hodgkin Lymphoma.

Previous applications

1519.1 – Tisagenlecleucel (CTL019) for treatment of relapsed or refractory diffuse large B-cell lymphoma
1519 – Tisagenlecleucel (CTL019) for treatment of refractory CD19-positive leukaemia and lymphoma

Application documents

Public summary document

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Meetings to consider this application

  • PASC meeting: Expedited – bypassing PASC
  • ESC meeting: Expedited – bypassing ESC
  • MSAC meeting: 26 to 27 November 2020