Patients with blood cancers will benefit with a breakthrough CAR-T therapy now to be made in Australia for the first time, within the Peter MacCallum Cancer Centre.

Australians who receive Novartis’ CAR-T therapy Kymriah® (tisagenlecleucel) currently have their blood collected and sent overseas. Final approvals have now been received allowing Cell Therapies Pty Ltd, which operates a state-of-the-art facility within Peter Mac, to manufacture this treatment in Victoria.

“This is a major win for Australian patients with blood cancer who will benefit from improved access to this potentially lifesaving therapy,” Peter Mac Chief Executive Dr Shelley Dolan said. “It is fantastic that Melbourne will become one of only a handful of approved CAR-T manufacturing sites globally, reflecting Peter Mac’s national leadership in the emerging field of cancer immunotherapy.”

CAR-T therapy is a once-off, individualised treatment that uses the patient’s own reprogrammed T-cells to fight their cancer. It is primarily used to treat blood cancers however clinical trials are underway to apply CAR-T therapies to solid tumours.

Peter Mac has pioneered CAR-T therapy in Australia for more than 10 years, and performed Australia’s first CAR-T clinical trial in 2007. In 2019, the Commonwealth Government announced $80M funding to establish the Centre of Excellence in Cellular Immunotherapy at Peter Mac, co-funded by Peter Mac and the Peter MacCallum Cancer Foundation ($25M).

In early 2020, Novartis announced its intention to use Cell Therapies, majority owned by Peter Mac, as a manufacturing site. Today’s approval by the Therapeutic Goods Administration allows Cell Therapies to begin onshore manufacture of Kymriah®.

“This is a significant day for Cell Therapies, and represents many years of investing in our facility, technology and our people to develop this capability,” says Cell Therapies Acting Chief Executive Associate Professor Dominic Wall, who is also Peter Mac’s Executive Director Business Ventures. “We now look forward to making this CAR-T therapy onshore for patients in Australia and the broader Asia Pacific region.”

Subsidised access to CAR-T therapy is available for eligible Australians 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).


For more information contact the Peter Mac Communications team on 0417 123 048.

About Peter Mac

Peter MacCallum Cancer Centre is a world-leading cancer research, education and treatment centre and Australia’s only public health service solely dedicated to caring for people affected by cancer.