Roche’s cancer drug, Gazyva, has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adults with active lupus nephritis, expanding its use from oncology to autoimmune diseases. This decision, announced on March 25, 2024, allows Gazyva to be administered alongside standard therapies for lupus nephritis, a serious condition affecting kidney function.
Lupus nephritis occurs as a complication of systemic lupus erythematosus, where the immune system mistakenly attacks the body’s tissues. In this condition, autoantibodies can cause significant kidney inflammation, leading to the loss of nephrons—critical components of the kidneys that filter blood. The irreversible loss of these units can result in worsening kidney function, leaving many patients at risk of developing end-stage kidney disease, which necessitates dialysis or transplantation. According to Roche, over 1.7 million people globally suffer from lupus nephritis, with the majority being women.
Gazyva, an intravenously infused monoclonal antibody, works by targeting and depleting B cells, a type of immune cell involved in the inflammatory response. By binding to CD20, a protein present on B cells, Gazyva triggers cell death, thereby reducing the inflammation associated with autoimmune diseases. Originally approved in 2013 for chronic lymphocytic leukemia, the drug is now positioned as a promising option for lupus nephritis.
The FDA’s approval was based on data from a placebo-controlled Phase 3 clinical trial, which assessed the drug’s efficacy alongside standard immunosuppressive and anti-inflammatory treatments. Results indicated that approximately 46.4% of participants receiving Gazyva achieved a complete renal response, in contrast to 33.1% of those receiving a placebo. The trial also demonstrated significant improvements in protein levels linked to autoimmune activity and a reduction in corticosteroid usage.
Levi Garraway, Roche’s Chief Medical Officer and head of global product development, emphasized the significance of this approval, stating, “People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevent, progression to end-stage kidney disease.” He noted that Gazyva’s approval represents a potential new standard of care for lupus nephritis, offering clinicians more effective options for disease management.
With the approval of Gazyva, Roche now provides a biologic alternative to GSK’s Benlysta, the first biologic treatment for lupus approved by the FDA in 2011. Benlysta, which inhibits BlyS—a protein crucial for B cell survival—expanded its indication to lupus nephritis in 2020. GSK reported revenues of £1.5 billion (approximately $2 billion) for Benlysta in 2024, marking a more than 10% increase from the previous year.
In addition, AstraZeneca received FDA approval for its biologic Saphnelo, which is currently approved only for systemic lupus erythematosus, not lupus nephritis. Gazyva, marketed as Gazyvaro in Europe, has already secured approval in 100 countries for various blood cancers, generating 910 million Swiss francs (around $1.15 billion) in revenue for Roche in 2024, reflecting a 12.2% increase from the prior year.
Roche is also pursuing additional indications for Gazyva, with ongoing clinical trials evaluating its effects in systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and in pediatric populations with lupus nephritis. Recently, a committee from the European Medicines Agency recommended approval of Gazyva for lupus nephritis, indicating a potential expansion of its use in Europe.
This latest approval signifies a notable advancement in the treatment landscape for lupus nephritis, positioning Roche’s Gazyva as a critical option for patients battling this challenging autoimmune disease.
