What Is Gazyva, and Why Does It Matter?
Gazyva (obinutuzumab) is a lab-made antibody medication used for treating certain blood cancers. The FDA recently approved the combined use of Gazyva and standard therapy in adults having an active kidney disease known as lupus nephritis (LN). Gazyva works by binding to CD20, a protein found on the surface of certain types of B cells that can malfunction, trigger inflammation, and worsen the disease. By targeting CD20, Gazyva helps the immune system to recognize and destroy these harmful B cells.
LN affects more than 1.7 million people worldwide, mostly women of color and those of childbearing age. It is a serious and potentially life-threatening kidney complication of lupus, an autoimmune disease in which the immune system mistakenly attacks tissue. Faulty or overactive B cells drive persistent inflammation that damages and impairs kidney function, leading to chronic pain and fatigue that significantly disrupt daily life. If not treated, LN may cause long-term complications including kidney failure.
Gazyva is the first anti-CD20 antibody that fully improved kidney function in a large clinical study of people with LN. This means that it may help protect your kidneys and potentially prevent or delay progression to end-stage kidney disease, especially if other treatment methods haven’t worked well. First approved in 2023, Gazyva is also used with other medicines to treat blood cancers such as chronic lymphocytic leukemia and follicular lymphoma.
Why Was It Approved?
The FDA’s approval of Gazyva is based on a clinical study which showed that in adult patients with LN, a combination of Gazyva and standard therapy significantly improved kidney health and function, compared with those who received standard therapy alone.
In the study involving 271 adult patients with active or long-standing LN, nearly half of the people (46.4%) who took Gazyva with standard treatment showed a complete kidney response after about a year and a half (76 weeks) compared with 33.1% of those who took standard therapy alone. This was also linked to other signs of better disease control such as improved immune marker levels, lower anti-dsDNA levels, reduced need for steroids, and less protein in the urine.
The safety profile of Gazyva aligns with what has already been well established in its use for blood and cancer-related conditions. The most common side effects include reactions during the infusion, low white blood cell counts, and infections such as bronchitis, pneumonia, and urinary tract infection.
What Do I Need to Know?
Gazyva is given through an intravenous infusion by a health care provider. For LN, you’ll usually get four doses in the first year, followed by two maintenance doses each year after that. It is used along with standard treatment options like mycophenolate mofetil and steroids.
Before each infusion, you’ll get medicines like acetaminophen, antihistamines, and steroids to help prevent infusion reactions. Severe bacterial, fungal, and new or reactivated viral infections can occur during and after Gazyva therapy. Some serious risks include hepatitis B coming back and a rare brain infection called progressive multifocal leukoencephalopathy, which can be life-threatening. Because of these risks, your health care provider will check for hepatitis B before, during, and for several months after the treatment and will also monitor your blood counts and kidney function.
You should not take Gazyva if you’ve had a serious allergic reaction to it or to any of its ingredients. Inform your health care provider if you have an ongoing infection or if you have an infection that does not go away or keeps coming back. Avoid live vaccines while on Gazyva and for several months after your last dose. Be sure to tell your doctor about all your vaccinations and the medicines that you take, including over-the-counter products, herbal remedies, and vitamin supplements.
If you’re pregnant, planning to become pregnant, or breastfeeding, talk to your health care provider before taking the medicine as it can harm a fetus or pass into breast milk. If you’re able to become pregnant, use birth control during treatment and for six months afterward. Breastfeeding is not recommended during this time either.
Contact your health care provider right away if you have fever or notice any other signs of infection, unusual bleeding or bruising, or any changes in your preexisting neurological condition.