Access to CAR T-cell therapy expanded as local manufacture starts this year


By Mardi Chapman

3 Feb 2020

Access to subsidised CAR T-cell therapy tisagenlecleucel (Kymriah) will be expanded to include adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma and primary mediastinal B cell lymphoma.

Previously, subsidised therapy was only provided to children and young adults with acute lymphoblastic leukaemia (ALL).

The announcement from the Federal Health Minister Greg Hunt follows a decision turnaround by MSAC, which, as reported in the limbic late last year, initially rejected an application for the DLBCL indication.

The Minister’s statement said between 200 and 250 patients with DLBCL were expected to benefit from access to the CAR T-cell therapy each year.

Without government funding, treatment would cost more than $500,000 for each patient, it said.

The therapy will also be manufactured locally in Melbourne rather than overseas thanks to a partnership between the Peter MacCallum Cancer Centre and Novartis.

Transfer of manufacturing capabilities to Peter MacCallum is expected to be achieved by the second half of 2020 resulting in substantially less time from patient blood collection to re-infusion of the modified cells.

“Being able to complete this whole process within Australia – and, in fact, entirely within Peter Mac – is a real game changer for Australian patients who need this treatment and their clinicians,” said Associate Professor Dominic Wall,  Executive Director at Peter Mac responsible for cellular immunotherapy.

“On-shore manufacture removes a major bottle-neck of international transport while patients benefit from substantially less time needed from blood collection to reinfusion.”

Clinicians and patient support groups welcomed the announcements.

Dr Michael Dickinson, deputy director of the Centre of Excellence in Cellular Immunotherapy at Peter MacCallum said improved access to the CAR T-cell therapy was a milestone in cancer treatment.

“The decision to fund Kymriah for eligible patients with relapsed and refractory diffuse large B- cell lymphoma will dramatically change our treatment approach for this disease in Australia,” he said in a statement issued by Novartis.

Leukaemia Foundation CEO Bill Petch said it represented further progress towards the goal of zero lives lost to blood cancer by 2035.

“To have this innovative treatment manufactured locally in Melbourne at the same facility where it will be used to treat patients improves its accessibility and represents a significant leap in Australia’s support for CAR-T therapy broadly,” he said.

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