FDA approves Roche cancer drug, bringing new biologic option to lupus nephritis
One of Roche's top cancer drugs has won FDA approval to treat lupus nephritis, and the drug is expanding into autoimmune diseases.
The intravenous drug Gazyva is now available to treat adults with active lupus nephritis who are receiving standard treatments. The regulatory decision announced on Monday brings another biologic treatment to the disease, joining a blockbuster product from GlaxoSmithKline.
Lupus nephritis is a complication of systemic lupus erythematosus, a disease in which the immune system mistakenly attacks the body's own tissues and organs. In lupus nephritis, autoantibodies cause inflammation of the kidneys, leading to the loss of nephrons, the functional units of the kidneys that filter blood to produce urine. Irreversible loss of nephrons leads to deterioration of kidney function; many patients progress to end-stage renal disease and require dialysis or kidney transplantation. According to Roche, more than 1.7 million people worldwide have lupus nephritis, the majority of whom are women.
Gazyva works by eliminating B cells, a type of immune cell. The drug is a monoclonal antibody designed to bind to CD20, a protein on the surface of B cells. This approach triggers mechanisms that lead to cell death. Abnormal B cells can cause blood cancers, and Gazyva was first approved in 2013 to treat chronic lymphocytic leukemia. But B cells can also drive the persistent inflammation behind autoimmune diseases, and Gazyva is the latest example of a cancer drug finding new applications in immunology.
Roche's submission to the FDA for lupus nephritis is supported by a placebo-controlled Phase 3 clinical trial that evaluated Gazyva in addition to standard therapies (immunosuppressants and anti-inflammatory drugs). Results showed that nearly 46.4% of patients in the study drug group achieved complete renal remission, compared with 33.1% of patients who received placebo and standard care. Results also showed clinically meaningful improvements in protein level measurements indicative of autoimmune disease and reduced corticosteroid use.
Gazyva's safety profile is consistent with the drug's performance in blood cancers. The most common adverse reactions reported in cancer clinical trials include infusion-related reactions; abnormally low levels of neutrophils (a type of white blood cell); and upper respiratory tract infections.
“Lupus nephritis patients who achieve a complete renal response are more likely to retain kidney function and delay or even prevent progression to end-stage renal disease,” Levi Garraway, Roche's chief medical officer and head of global product development, said in a prepared statement. “The FDA's approval of Gazyva marks an important step toward a potential new standard of care for lupus nephritis that could allow clinicians to provide patients with more effective disease control.”
With the new approval of Gazyva, Roche can offer patients a biologic alternative to GSK's established product Benlysta, an antibody designed to inhibit BlyS, a key protein for B cell survival. Benlysta was approved by the FDA in 2011 for the treatment of systemic lupus erythematosus, making it the first biologic to treat an autoimmune disease. In 2020, the drug expanded its label to include lupus nephritis. GSK reports that Benlysta's revenue will reach 1.5 billion pounds (approximately $2 billion) in 2024, an increase of more than 10% on the previous year's sales. In 2021, AstraZeneca's biologic drug Saphnelo was approved by the FDA, but this antibody drug is only approved for systemic lupus erythematosus.
Roche's Gazyva (Gazyvaro in Europe) is approved in 100 countries to treat various types of blood cancers. Roche reported revenue from this product of 910 million Swiss francs (approximately $1.15 billion) in 2024, an increase of 12.2% over the previous year. Gazyva in lupus nephritis remains under regulatory review in Europe. Last week, the European Medicines Agency committee recommended approval of the product for the treatment of autoimmune diseases. Roche is considering further expansion of the Gazyva brand. Clinical trials are ongoing in children and adolescents with systemic lupus erythematosus, membranous nephropathy, idiopathic nephrotic syndrome, and lupus nephritis.
Photo: peterschreiber.media, Getty Images
