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Therapeutic Goods Administration (TGA) has today approved the use of the first CAR-T therapy in Australia

Thursday 18 January 2020
Therapeutic Goods Administration (TGA) has today approved the use of the first CAR-T therapy in Australia.

A revolutionary cancer therapy that supercharges a patient’s immune cells to hunt and destroy cancer cells has been approved for use in Australia, ushering in a new era in medicine.

The TGA has approved Kymriah® (tisagenlecleucel, formerly CTL019) CAR-T therapy for use in paediatric and young adult patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant, or in second or later relapse.

The therapy is also approved for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of systemic therapy. Publicly-subsidised access through the Medicare Benefits Schedule (MBS) has not yet occurred.

CAR-T therapy involves extracting a patient’s own beleaguered immune cells and genetically re-engineering them before infusing them back into the body. The single-shot “living drug” has generated enormous excitement in the medical world.

Results from the ELIANA CAR-T cell clinical triali in children and young adult patients with relapsed or refractory ALL show an 82% remission rate within 3 months and a 62% relapse-free survival after 2 years.

While for some patients, CAR-T therapy will lead to a cure, other patients will relapse meaning the therapy will be used as the mechanism to lead to remission to enable a stem cell transplant as the next line treatment option.

The CAR-T therapy will be available at three treatment centres in Australia, including Royal Prince Alfred Hospital in Sydney, and Peter MacCallum Cancer Centre and Royal Melbourne Children’s Hospital in Melbourne. Patients are required to privately pay for the treatment which is estimated at around $598,000 in costs for the therapy alone.

The Leukaemia Foundation applauds the TGA approval and confirmed this is a step closer to ensure Australians living with blood cancer have equal and affordable access to the latest cutting-edge treatments, as soon as possible.

“We know targeted therapy; precision medicines and immunotherapies are leading the way in blood cancer treatments and we are committed to driving development in this area,” a Leukaemia Foundation spokesperson said.

Federal Health Minister Greg Hunt said the Government’s goal is to make Australia one of the global treatment centres for CAR-T therapy.

He said he was working closely with State and Territory ministers to provide access to patients through the public system as soon as possible. 

The Leukaemia Foundation strongly advocates for CAR-T therapy to be publicly subsidised in Australia and has committed to supporting patients with free emotional and practical support including accommodation close to each treatment centre for the full duration of the treatment period.

“Whether you live in a metropolitan city or a rural town, access to new therapies will be a critical component and it’s our priority to ensure all Australians living with a blood cancer have support and equal access to the treatment they need,” the Leukaemia Foundation spokesperson said.

Acute lymphoblastic leukaemia (ALL) is a type of cancer that affects the blood and bone marrow. ALL is characterised by an overproduction of immature white blood cells, called lymphoblasts or leukaemic blasts. More than 300 adults and children are diagnosed with ALL each year in Australia.

DLBCL is an aggressive type of non-Hodgkin lymphoma that develops from the B-cells in the lymphatic system. It is the most common subtype of non-Hodgkin lymphoma accounting for 30%-40% of all cases in Australia, which equates to around 1500 people newly diagnosed each year.

The Leukaemia Foundation provides free practical and emotional support to Australian’s diagnosed with a blood cancer including ALL and DLBCL.


Last updated on July 15th, 2022

Developed by the Leukaemia Foundation in consultation with people living with a blood cancer, Leukaemia Foundation support staff, haematology nursing staff and/or Australian clinical haematologists. This content is provided for information purposes only and we urge you to always seek advice from a registered health care professional for diagnosis, treatment and answers to your medical questions, including the suitability of a particular therapy, service, product or treatment in your circumstances. The Leukaemia Foundation shall not bear any liability for any person relying on the materials contained on this website.