Expanded access to CAR T-cell therapies in Ireland for adults with certain blood cancers

Gilead Sciences Ltd. and Kite, a Gilead company, have announced that two CAR T-cell therapies have been reimbursed through the public health system in Ireland for the treatment of eligible adult patients with certain blood cancers.

Yescarta® (axicabtagene ciloleucel; axi-cel) is now reimbursed in Ireland as an option for eligible adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months of completion of, or is refractory to, first-line treatment.

DLBCL is an aggressive form of non-Hodgkin lymphoma and is the most common type of lymphoma in Ireland, accounting for around one-third of all non-Hodgkin lymphomas and four out of five high-grade cases. While 50 to 60 per cent of newly diagnosed DLBCL patients respond to initial treatment, around 30 to 40 per cent will relapse or not respond, meaning additional treatment options may be needed.

Tecartus® (brexucabtagene autoleucel; brexu-cel) has also been reimbursed in Ireland for eligible adult patients aged 26 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

ALL is an acute haematological malignancy and represents approximately 11 per cent of all leukaemias in Ireland. Although advances in chemotherapy and targeted immunotherapies have improved overall survival, relapsed or refractory adult ALL remains associated with poor outcomes.

CAR T-cell therapies are individually manufactured using a patient’s own white blood cells, known as T-cells. These cells are collected through a process similar to platelet or plasma donation and sent to specialised manufacturing facilities, where they are engineered to target cancer cells before being returned to the hospital for infusion back into the patient.

Commenting on the reimbursement, Dr Julian Cole, Executive Director of Medical Affairs at Gilead Sciences, said: “The reimbursement of these CAR T-cell therapies represents an important development for eligible adult patients in Ireland with relapsed or refractory blood cancers. Continued collaboration is important to ensure that the process is accelerated and improved for the recent waves of innovative cancer medicines and that there is equitable access to such treatments for all eligible patients.”

About Yescarta®

Yescarta is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for:

• adult patients with DLBCL and HGBL that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy
• adult patients with relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy
• adult patients with relapsed or refractory follicular lymphoma after three or more lines of systemic therapy

About Tecartus®

Tecartus is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for:

• adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase inhibitor
• adult patients aged 26 years and older with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia

For full details on special warnings, precautions for use and adverse reactions, readers are advised to consult the Summary of Product Characteristics.