FDA starts review of Roche's Gazyva in lupus nephritis

Roche's anti-CD20 antibody Gazyva has been on the market for more than a decade as a treatment for blood cancer, but could see a new lease of life if it gets FDA approval to treat kidney disease caused by the autoimmune disorder systemic lupus erythematosus (SLE).

The US regulator has started a review of Roche's supplemental biologics license application (BLA) for Gazyva/Gazyvaro (obinutuzumab) as a treatment for lupus nephritis, with a decision expected in October. The FDA has awarded breakthrough status to the drug in this indication.

The filing is based on the results of the phase 3 REGENCY study, which showed an improved complete renal response (CRR) rate with Gazyva plus standard therapy with mycophenolate mofetil and steroids compared with standard therapy alone.

After 76 weeks of follow-up, the CRR was 46.4% for the Gazyva group compared to 33.1% for the control arm, according to data published in February in the New England Journal of Medicine.

The primary results were accompanied by "clinically meaningful" improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation, according to Roche - although, Gazyva wasn't able to hit some secondary objectives in the study, including measures of kidney function and survival.

Lupus nephritis is a severe form of SLE that can lead to late-stage renal failure and require dialysis or even a kidney replacement in the most severe cases. It affects 1.7 million people worldwide, according to Roche, which estimates that up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years.

If approved, Gazyva will become an alternative to other therapies for lupus nephritis, including GSK's Benlysta (belimumab), which became the first FDA-approved, targeted treatment for the disorder in 2020, and Aurinia Pharma's oral immunosuppressant Lupkynis (voclosporin), which was cleared by the FDA in 2021.

"Given the relatively young age of onset, people with lupus nephritis experience more years of disease-related complications and decreased quality of life due to the significant burden of this illness," said Louise Vetter, president and chief executive of the Lupus Foundation of America.

"We are hopeful for a new treatment option that can effectively reduce these risks and improve the health of all people affected by this disease."

Gazyva has also been filed for the lupus nephritis indication in Europe, said Roche, which is also expecting a readout from the phase 3 ALLEGORY trial in a broader SLE population later in 2025 and, if approved for that use, will be rival to AstraZeneca's Saphnelo (anifrolumab).

GlobalData has said that approval for lupus nephritis and SLE could drive sales of Gazyva to $1.7 billion by the end of the decade. Last year, it made just over $1 billion from its use in chronic lymphocytic leukaemia (CLL) and follicular lymphoma (FL).