Roche marks first CD20-directed therapy PBS-listed for lupus nephritis

Roche is marking a new milestone for its blood cancer drug Gazyva (obinutuzumab), with the monoclonal antibody therapy becoming the first CD20-directed treatment to be listed on the Pharmaceutical Benefits Scheme (PBS) for severe kidney disease caused by lupus nephritis.

From 1 September, Gazyva will be PBS-funded for eligible patients with lupus nephritis, a potentially fatal manifestation of systemic lupus erythematosus (SLE), the most common form of lupus. Many people living with the disease experience progressive deterioration in kidney function and up to one-third progress to end-stage kidney disease.

“The addition of this new therapy to the PBS is a significant development in how we treat lupus-related kidney disease in Australia,” explained Professor Eric Morand, Director of Rheumatology at Monash Health and Monash University. “While current therapies provide benefit for many, ongoing inflammation remains a challenge for a number of patients. Now, for the first time we can prescribe a treatment that specifically targets the drivers of inflammation in lupus kidney disease.”

More than 16,000 Australians are living with lupus, the majority of them women of childbearing age. The burden of lupus nephritis is particularly pronounced among Aboriginal and Torres Strait Islander peoples, who experience more rapid progression to kidney failure.

“Without prompt and effective treatment, many people with lupus nephritis will progress to permanent and irreversible kidney damage, and ultimately kidney failure,” said Professor Morand. “The impact is even more severe among Aboriginal and Torres Strait Islander peoples, who have significantly higher rates of lupus nephritis and faster progression to kidney failure.”

Evidence underpinning the PBS listing comes from the Regency trial, in which 46% of patients treated with Gazyva alongside standard therapy achieved a complete renal response, compared with 33% of patients receiving standard care alone. Standard care consisted of the immunosuppressive agent mycophenolate mofetil and glucocorticoids.

The trial’s primary endpoint results were characterised as statistically significant and clinically meaningful. However, Gazyva did not meet its secondary endpoints for mean change in estimated glomerular filtration rate (eGFR), death or renal-related events, and overall renal responses.

“Sadly, up to a third of Australians with lupus-related kidney disease will develop kidney failure within 10 years, with dialysis or kidney transplant their only treatment options. This highlights the urgent need for expanded treatment options and continued innovation for Australia’s lupus community,” Professor Morand added.

For patients and advocates, the PBS listing represents a new treatment option in a disease area where therapeutic choices remain limited.

“For people living with lupus, this is about hope,” said Melinda Barrett, Vice Chair, Lupus Voice Australia. “Our community has waited a long time for progress, and we are finally beginning to see it.”

Dr Nic Horridge, General Manager of Roche Pharmaceuticals Australia, described the PBS listing of Gazyva as an “important milestone in a disease area of high unmet need”.

“Innovative medicines drive economic growth by keeping people healthy and productive,” stated Dr Horridge. “We are pleased to play our part in bringing this first-of-its-kind treatment to Australians with lupus nephritis. This would not have been possible without the advocacy of the lupus community – so I want to thank them for making their voices heard.”

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