Approval for Australian CAR-T therapy manufacturing site to deliver faster access to innovative treatment for patients with aggressive blood cancers
Friday February 12, 2021
Breakthrough CAR-T therapy is now another step closer to being manufactured in Australia for the first time, allowing faster access to the innovative treatment for eligible Australians with life-threatening blood cancers.
The Therapeutic Goods Administration (TGA) has now granted approval for Cell Therapies Pty Ltd to commence commercial manufacturing of Kymriah® (tisagenlecleucel) in its manufacturing facility at Melbourne’s Peter MacCallum Cancer Centre.
The approval, announced today, means the site becomes the first and only approved commercial manufacturing hub for CAR-T therapy in the country for both clinical trial and non-clinical trial patients, securing supply of the state-of-the-art treatment onshore.
Primarily used to treat blood cancers, CAR-T therapy is a once-off, individualised treatment that uses the patient’s own reprogrammed T-cells to fight their cancer. The treatment involves extracting a patient’s own immune cells and genetically re-engineering them before infusing them back into the body.
For some patients CAR-T therapy will lead to a cure. Where other patients relapse, the therapy will be used as the mechanism to lead to remission to enable a stem cell transplant as the next line treatment option.
Today’s announcement comes after the TGA last year approved the use of CAR-T therapy in Australia for some Australians with aggressive lymphoma and leukaemia, and also follows an $80 million investment by the Federal Government to establish the Peter MacCallum Cancer Centre as a new base for CAR-T therapy and other immunotherapy clinical trials.
Leukaemia Foundation CEO Chris Tanti applauded the approval, saying the organisation recognised CAR-T therapy as a potential gamechanger in the treatment of patients with aggressive blood cancers and local manufacturing means improved security of supply and greater local capacity to deliver CAR-T therapy to these Australians.
“Until now, Australians with blood cancer receiving this therapy had to have their cells shipped overseas to the USA, so approval for this advanced manufacturing process to remain onshore means that from start to finish, this treatment can be produced and delivered here, and therefore more efficiently,” he said.
“For Australians diagnosed with aggressive blood cancers, every day counts in their treatment journey, and today’s announcement represents faster and easier access to a potential lifeline for some of these patients right here, right now, which is an incredible win.
“Targeted treatments, precision medicine and immunotherapies are changing the face of how we tackle blood cancer in this country. The Leukaemia Foundation is committed to driving development in this area and strongly supports any initiatives to fast-track and increase access to innovations like CAR-T therapy as we set our sights on the blood cancer community’s shared vision to achieve zero lives lost to blood cancer by 2035.”
Subsidised access to CAR-T therapy is available for eligible Australian patients with relapsed or refractory Diffuse Large B Cell Lymphoma (DLBCL), and eligible paediatric or young adult (up to 25 years) patients with relapsed or refractory Acute Lymphoblastic Leukaemia (ALL).
To date, more than 100 Australians have been treated with CAR-T therapy across clinical trials and commercially available therapy in seven treatment sites spanning Victoria, New South Wales, Queensland and Western Australia.
The Leukaemia Foundation 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 while undergoing CAR-T therapy.
“Whether you live in a capital city or a rural township, access to new blood cancer therapies is a critical factor influencing survival and it’s our priority to ensure all Australians living with a blood cancer have equal access to the best treatment possible, no matter where they call home,” Mr Tanti said.