The TGA has approved Cell Therapies to commence the commercial production of Novartis' CAR-T cell therapy KYMRIAH at the Peter MacCallum Cancer Centre in Melbourne.
Novartis said the approval makes Cell Therapies the first and only approved commercial manufacturing site for CAR-T in Australia.
KYMRIAH was the first CAR-T therapy approved and publicly funded in Australia. It is currently funded for the treatment of relapsed or refractory DLBCL (diffuse large B cell lymphoma) and paediatric and young adult patients up to 25 years of age with relapsed or refractory ALL (acute lymphoblastic leukaemia).
Australian patients have been accessing KYMRIAH produced overseas, including in the US. Novartis said over 100 Australians have been treated in clinical trials and with commercially available therapy in seven treatment sites across Victoria, New South Wales, and Queensland and Western Australia.
"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," said Cheryl Maley, the general manager of oncology for Novartis Australia and NZ.
"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."
"This important milestone is good news for patients, the clinical community and the economy," said Associate Professor Dominic Wall, executive director of business ventures at Peter MacCallum Cancer Centre and interim CEO at Cell Therapies "We anticipate this announcement will provide a significant economic boost through the creation of new highly-skilled jobs, now and into the future."
The Kymriah manufacturing process is complex. A patient's cells are first extracted then reprogrammed in the manufacturing facility and returned as a personalised, one-time treatment for infusion back into the patient.
"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. Our manufacturing set-up has been highly collaborative and successfully executed despite the challenges of COVID-19," added Associate Professor Wall.
"Local manufacturing means patients' cells can stay here in Australia without the need to ship them overseas, generating greater efficiencies and an expectation of quicker timelines tor eligible patients to access Kymriah," said Professor Simon Harrison, director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre.
