FDA approves Gazyva as lupus nephritis treatment
Genentech drug gets US approval as add-on treatment for disease
The U.S. Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab) as an add-on treatment for adults with lupus nephritis, a form of lupus marked by kidney damage.
“The approval of Gazyva by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, a Roche subsidiary, said in a company press release. In the U.S., Gazyva is part of a collaboration between Genentech and Biogen.
Lupus is an autoimmune disorder driven by antibodies that target the body’s own healthy tissues. In lupus nephritis, the kidneys are hit especially hard. Gazyva is designed to kill B-cells, immune cells chiefly responsible for making antibodies. The drug aims to reduce levels of lupus-driving antibodies, lessening inflammation.
The therapy, which targets a B-cell protein called CD20, is FDA approved to treat certain types of blood cancer that are caused by the uncontrolled growth of B-cells.
Gazyva is given by infusion into the bloodstream. For lupus nephritis, the first two infusions are done two weeks apart. Six months later, patients receive another two infusions two weeks apart. Infusions are given once every six months thereafter. Genentech says patients who do not have serious infusion-related reactions during or within 24 hours of the first infusion may be able to receive infusions in shorter, 90-minute periods.
Trial results show promise for patients
The FDA’s approval for lupus nephritis was based on data from the Phase 2 NOBILITY clinical trial (NCT02550652) and the Phase 3 REGENCY clinical trial (NCT04221477). Both trials tested Gazyva against a placebo in lupus nephritis patients who were already on standard-of-care therapies, with the main goal of testing whether patients given Gazyva were more likely to experience a complete kidney response — meaning normalization in markers of kidney damage.
“People with lupus nephritis who achieve a complete renal response are more likely to experience preserved kidney function and delay, or even prevention, of progression to end-stage kidney disease,” Garraway said.
In the NOBILITY trial, patients on Gazyva were significantly more likely to have a complete kidney response; at 1.5 years, rates of response were more than twice as high in patients given the therapy than the placebo (40% vs. 18%). Gazyva also reduced the risk of disease flares and kidney function decline. The REGENCY trial likewise showed that patients given Gazyva had higher rates of complete kidney response than those given the placebo after 1.5 years of treatment (46.4% vs. 33.1%).
According to its prescribing information, the most common side effects of Gazyva in lupus nephritis patients include upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion-related reactions, and low levels of immune cells called neutrophils. The therapy’s label includes a boxed warning — the FDA’s most stringent safety warning — noting that it can increase the risk of certain life-threatening infections.
Gazyva is being considered for approval as a lupus nephritis treatment in the European Union. A European Medicines Agency committee recently gave a positive recommendation for approval, and a final decision is expected “in the near future,” Genentech said.
Community advocates praised the FDA’s decision. “As a severe and potentially life-threatening disease, lupus nephritis greatly disrupts daily life with chronic pain, fatigue, and the constant fear of worsening kidney health,” said Louise Vetter, president and CEO of the Lupus Foundation of America. “The FDA’s approval of Gazyva offers renewed hope for people with lupus nephritis and their loved ones, as it provides an important new treatment option that has the potential to prevent long-term complications, including kidney failure.”
“Given how many people living with lupus develop lupus nephritis and experience its severe complications, it is critical to have more treatment options available,” Albert T. Roy, president and CEO of the Lupus Research Alliance, said in an alliance press release. “As preserving kidney function is crucial for people with lupus, this U.S. FDA approval is an important milestone – bringing a new treatment with a positive safety and effectiveness profile.”
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