South San Francisco, CA — September 25th, 2026 —
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), has received U.S. Food and Drug Administration (FDA) approval of Gazyva® (obinutuzumab) to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome (INS) who are in complete remission. INS is a rare, kidney-related autoimmune disease, usually diagnosed in early childhood. In the Phase III INShore study, a greater proportion of people experienced no relapses after week 8 and were in complete remission at one year (week 52) with Gazyva (95%) compared with mycophenolate mofetil (MMF) (73%). Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva with an increase in those with overall relapse-free survival (RFS), median time to first relapse or death, and fewer relapses from baseline to week 52, all compared with MMF. No new safety signals were observed.
“Gazyva is the first FDA-approved treatment option for idiopathic nephrotic syndrome in 70 years, introducing a substantial advancement for children and families who have long relied on steroids and faced high rates of relapse,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “By directly targeting B cells to more effectively control disease activity, this first-of-its-kind therapy equips healthcare providers with an option that provides the possibility of lasting remission, giving families the freedom to focus on their child’s growth and potential."
“For too long, patients living with INS have had to endure unpredictable relapses, prolonged steroid use, and the constant threat of disease progression,” said Andi Callaway, founder and president, The Nephrotic Syndrome Foundation. “This approval of Gazyva marks a shift that enables patients and families facing this debilitating disease to raise expectations for care and look ahead with optimism for a brighter future.”
This is the second FDA approval of Gazyva in immune-mediated disease, following the approval in adult lupus nephritis (LN) last year. The FDA granted Breakthrough Therapy Designation (BTD) to Gazyva in both conditions and granted Priority Review for Gazyva in INS. Gazyva is also being investigated in pediatric LN and is under FDA review in primary membranous nephropathy and systemic lupus erythematosus (SLE), based on the positive Phase III MAJESTY and ALLEGORY trials, respectively. These milestones contribute to a growing body of evidence that supports the potential of Gazyva to address disease activity across a spectrum of immune-mediated kidney and kidney-related diseases.
What is Gazyva?
GAZYVA® (obinutuzumab) is a prescription medicine used to treat adults and children 2 years of age and older with childhood-onset idiopathic nephrotic syndrome (INS) whose condition relies on regular steroids (steroid dependent) or keeps coming back (frequently relapsing).
Important Safety Information
What is the most important safety information I should know about GAZYVA?
Tell your doctor right away about any side effects you experience. GAZYVA can cause side effects that can become serious or life-threatening, including:
Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If you have a history of hepatitis B infection, GAZYVA could cause it to return. You should not receive GAZYVA if you have active hepatitis B liver disease. Your doctor or healthcare team will need to screen you for hepatitis B before, and monitor you during and after, your treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis B include worsening of fatigue and yellow discoloration of skin or eyes
Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. Your weakened immune system could put you at risk. Your doctor will watch for symptoms. Symptoms of PML include confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems
Who should not receive GAZYVA?
Do NOT receive GAZYVA if you have had an allergic reaction (eg, anaphylaxis or serum sickness) to GAZYVA. Tell your healthcare provider if you have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past
What are additional possible serious side effects of GAZYVA?
Tell your doctor right away about any side effects you experience. GAZYVA can cause side effects that may become severe or life-threatening, including:
Infusion-Related Reactions (IRRs): These side effects may occur during or within 24 hours of any GAZYVA infusion. Some IRRs can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening IRRs. If you have a reaction, the infusion is either slowed or stopped until your symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion-related reaction is life-threatening, the infusion of GAZYVA will be permanently stopped. Your healthcare team will take steps to help lessen any side effects you may have to the infusion process. You may be given medicines to take before each GAZYVA treatment. Symptoms of IRRs may include fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort
Hypersensitivity Reactions, Including Serum Sickness: Some people receiving GAZYVA may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, your doctor will stop the infusion and permanently discontinue GAZYVA
Serious, Including Fatal, Infections: While you’re taking GAZYVA, you may develop infections. Some of these infections can be fatal and severe, so be sure to talk to your doctor if you think you have an infection. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA may be at higher risk for severe infections compared to patients taking mycophenolate mofetil. If you develop a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection
Low White Blood Cell Count: When you have an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While you are taking GAZYVA, your doctor will do blood work to check your white blood cell count. Severe and life-threatening neutropenia can develop during or after treatment with GAZYVA. Some cases of neutropenia can last for more than one month. If your white blood cell count is low, your doctor may prescribe medication to help prevent infections
Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA with chemotherapy may reduce the number of platelets you have in your blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While you are taking GAZYVA, your doctor will do blood work to check your platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If your platelet count gets too low, your treatment may be delayed or reduced
Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA for chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor, as it can lead to uncontrollable bleeding
The most common side effects of GAZYVA in childhood-onset INS were upper respiratory tract infection, infusion-related reactions, ear infection, pneumonia, influenza, neutropenia, bronchitis, COVID-19, conjunctivitis, and urinary tract infection.
What other information should I tell my doctor before receiving GAZYVA?
You should talk to your doctor about:
Immunizations: Before receiving GAZYVA therapy, tell your healthcare provider if you have recently received or are scheduled to receive a vaccine. People who are treated with GAZYVA should not receive live vaccines. In patients with childhood-onset INS, live vaccines should be received at least 28 days prior to treatment with GAZYVA
Pregnancy: Tell your doctor if you are pregnant, think that you might be pregnant, or plan to become pregnant. GAZYVA may harm your unborn baby. Speak to your doctor about using GAZYVA while you are pregnant. Talk to your doctor or your child’s doctor about the safety and timing of live virus vaccinations to your infant if you received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after GAZYVA treatment
Breastfeeding: Because of the potential risk of serious side effects in breastfed children, women should not breastfeed while taking GAZYVA and for 6 months after your last dose
Tell your doctor about any side effects.
These are not all of the possible side effects of GAZYVA. For more information, ask your doctor or pharmacist.
GAZYVA is available by prescription only.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the full Prescribing Information for additional Important Safety Information, including Serious Side Effects.
About idiopathic nephrotic syndrome
Idiopathic nephrotic syndrome is a rare, kidney-related autoimmune disease, usually diagnosed in early childhood. It is the most common form of primary glomerular disease in children. It is characterized by unpredictable relapses that cause fatigue, swelling, weight gain and increased susceptibility to infections and clotting, as well as anxiety, depression and reduced self-esteem, brought on by the fear of relapse and social isolation. The current mainstay of treatment is steroids, however relapse rates remain high (>70%) and steroid side effects can limit long-term use.
About Genentech
Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
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Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.