First Australian commercial CAR-T manufacturing site approved

Novartis has announced that its CAR-T therapy, Kymriah (tisagenlecleucel), will now be manufactured in Australia, bringing faster access to treatment for eligible Australians with life-threatening blood cancers.

The Therapeutic Goods Administration (TGA) has reportedly granted approval for Cell Therapies Pty Ltd to commence commercial manufacturing of Kymriah, a chimeric antigen receptor T cell (CAR-T) one-time treatment, in its manufacturing facility in the Peter MacCallum Cancer Centre in Melbourne.

The approval makes Cell Therapies the first and only approved commercial manufacturing site for CAR-T in Australia for both clinical trial and non-clinical trial patients.

“Novartis is extremely proud to have secured the approval for local manufacturing of Kymriah, which represents a substantial achievement for the clinical and patient community,” says General Manager Oncology, Novartis ANZ, Cheryl Maley.

“Australia now becomes one of the select countries in the world to locally manufacture CAR-T, demonstrating the advanced medical manufacturing capabilities we have here.

According to Executive Director of Business Ventures at Peter MacCallum Cancer Centre and Interim Chief Executive Officer at Cell Therapies Associate Professor Dominic Wall this approval is an “important milestone” and “is good news for patients, the clinical community and the economy”.

“We anticipate this announcement will provide a significant economic boost through the creation of new highly-skilled jobs, now and into the future,” he says.

Until now this advanced manufacturing process was conducted either in the Novartis Morris Plains facility in New Jersey, USA, or other approved overseas facilities.

“The manufacturing process for Kymriah requires an extraordinary amount of testing and quality control to ensure the reprogrammed cells created are compliant with the Good Manufacturing Practice (GMP) standards,” says Associate Professor Wall.

“Our manufacturing set-up has been highly collaborative and successfully executed despite the challenges of Covid-19.”

While brining the CAR-T therapy manufacturing to Australia is news for the community and the economy, Director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre Professor Simon Harrison adds that it will also mean that “patients’ cells can stay here in Australia without the need to ship them overseas”.

Professor Harrison explains that this will generate “greater efficiencies and an expectation of quicker timelines tor eligible patients to access Kymriah”.

Announcement represents faster and easier access to a lifeline

Leukaemia Foundation CEO Chris Tanti applauds the approval, saying the organisation recognised CAR-T therapy as a potential game changer 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,” says Mr Tanti.

“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.”

Leukaemia Foundation’s commitment

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 says.