- Priority review decision is based on Phase III MAJESTY results, where Gazyva achieved significantly higher complete remission rates at two years compared to tacrolimus
- If approved, Gazyva will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome
- pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--$RHHBY--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted priority review to the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). The priority review is based on the positive Phase III MAJESTY results, which show superiority of Gazyva over an immunosuppressive therapy, tacrolimus, in adults with pMN. The FDA has already granted Breakthrough Therapy Designation (BTD) to Gazyva in pMN and is expected to make a decision on approval by November 2026. This is the second indication in recent months for which the U.S. FDA has granted priority review to Gazyva following idiopathic nephrotic syndrome in May 2026.
“This priority review represents an important step for patients living with primary membranous nephropathy, a chronic disease with no FDA-approved treatments," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “By targeting tissue-resident B cells, Gazyva addresses an underlying cause of pMN and has the potential to help more patients achieve complete remission - a necessary step to maintaining kidney function.”
The Phase III MAJESTY study met its primary endpoint with 36.9% of adults achieving complete remission (CR) at two years (104 weeks) with Gazyva versus 5.7% with tacrolimus (adjusted difference 31.1%; 95% confidence interval [CI] 18.2 to 44.0; p<0.001). Complete remission is the ultimate goal in pMN and can help prevent progression to kidney failure. Key secondary endpoints showed that Gazyva was superior to tacrolimus in achieving overall remission (complete or partial remission) at week 104 and complete remission at week 76. Safety was in line with the well-characterized profile of Gazyva and no new safety signals were identified.
The data were featured at the 63rd European Renal Association (ERA) Congress in June 2026 as a late-breaking oral presentation and published in the New England Journal of Medicine (NEJM). In April 2026, the FDA granted Breakthrough Therapy Designation for Gazyva in pMN.
Data from MAJESTY are also being submitted to other global health authorities, including the European Medicines Agency.
pMN is a chronic autoimmune condition that causes potentially irreversible kidney damage and can lead to kidney failure, which has a significant impact on patients and their families, while carrying substantial burden to health systems. Achieving complete remission is important to help maintain kidney function and delay or prevent the onset of serious and potentially fatal complications.
MAJESTY is the fourth positive Phase III study of Gazyva in immune-mediated diseases, following REGENCY in lupus nephritis, ALLEGORY in systemic lupus erythematosus (SLE) and INShore in idiopathic nephrotic syndrome – where it received priority review and Breakthrough Therapy Designation by the FDA. Gazyva is approved in the U.S. and E.U. for the treatment of adults with active lupus nephritis who are receiving standard therapy based on data from the REGENCY and NOBILITY studies, and is being investigated in the Phase II POSTERITY study for children and adolescents with lupus nephritis. This growing body of evidence supports Gazyva’s potential in addressing disease activity across a spectrum of immune-mediated diseases.
Beyond Gazyva, we have a broad pipeline to bring breakthrough innovation across immunology, including immune-mediated kidney diseases. This includes Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell-engaging bispecific antibody being investigated in SLE.
About Gazyva
Gazyva® (obinutuzumab) is a humanized monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC). CD20 is a protein found on certain types of B cells. Gazyva is approved for adults with lupus nephritis in the U.S. and E.U. Gazyva is also approved in 100 countries for various types of hematological cancers.
About the MAJESTY Study
MAJESTY [NCT04629248] is a Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of Gazyva® (obinutuzumab) in adults with primary membranous nephropathy. The study enrolled 142 adults who were randomized 1:1 to receive Gazyva or tacrolimus. The primary endpoint is the percentage of adults who achieve complete remission at two years (week 104).
About Primary Membranous Nephropathy
Primary membranous nephropathy is a chronic autoimmune condition where the body’s immune system attacks the filtering units of the kidney, the glomeruli, causing protein to leak into the urine and potentially a gradual decline in kidney function. Over time, the damage to the kidneys can become irreversible, increasing the risk of life-threatening complications, such as kidney failure, idiopathic nephrotic syndrome, blood clots and cardiovascular disease. Achieving complete remission is important to help maintain kidney function and delay or prevent the onset of serious and potentially fatal complications.
Primary membranous nephropathy has an estimated incidence of 1.2 per 100,000 people in the United States per year.
GAZYVA Indications
GAZYVA® (obinutuzumab) is a prescription medicine used:
- With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment
- With the chemotherapy drug, bendamustine, followed by GAZYVA alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment
- With chemotherapy, followed by GAZYVA alone in those who responded, to treat stage II bulky, III, or IV FL in adults who have not had previous FL treatment
- for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy
Important Safety Information
The most important safety information patients should know about GAZYVA.
Patients must tell their doctor right away about any side effect they 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 the patient has a history of hepatitis B infection, GAZYVA could cause it to return. Patients should not receive GAZYVA if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen them for hepatitis B before, and monitor the patient for hepatitis during and after, their treatment with GAZYVA. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis 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. The patient’s weakened immune system could put them at risk. The patient’s 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:
Patients should NOT receive GAZYVA if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to GAZYVA. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in GAZYVA in the past.
Additional possible serious side effects of GAZYVA:
Patients must tell their doctor right away about any side effect they experience. GAZYVA can cause side effects that may become severe or life-threatening, including:
- Infusion-Related Reactions: These side effects may occur during or within 24 hours of any GAZYVA infusion. Some infusion-related reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion-related reactions. If the patient has a reaction, the infusion is either slowed or stopped until their 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. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each GAZYVA treatment. Symptoms of infusion-related reactions 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 patients 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, the patient’s doctor will stop the infusion and permanently discontinue GAZYVA
- Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving GAZYVA. GAZYVA works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart and may lead to kidney failure requiring the need for dialysis treatment. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness. TLS is not identified as a risk in LN
- Serious, Including Fatal, Infections: While the patient is taking GAZYVA, they may develop infections. Some of these infections may be fatal and severe, so the patient should be sure to talk to their doctor if they think they have an infection. Patients administered GAZYVA in combination with chemotherapy, followed by GAZYVA alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients taking GAZYVA plus standard therapy may be at higher risk for fatal or severe infections compared to patients taking standard therapy plus placebo. Patients with an active infection should not be treated with GAZYVA. Patients taking GAZYVA plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking GAZYVA plus CHOP or CVP. If the patient develops a serious infection, your doctor will immediately discontinue GAZYVA and begin treatment for the infection
- Low White Blood Cell Count: When the patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking GAZYVA, their doctor will do blood work to check their 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 the patient’s white blood cell count is low, their doctor may prescribe medication to help prevent infections
- Low Platelet Count: Platelets help stop bleeding or blood loss. GAZYVA may reduce the number of platelets the patient has in their blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking GAZYVA, their doctor will do blood work to check their platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with GAZYVA. Fatal bleeding events have occurred in patients treated with GAZYVA. If the patient’s platelet count gets too low, their treatment may be delayed or reduced
- Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by the patient’s doctor as it can lead to uncontrollable bleeding
The most common side effects of GAZYVA in CLL were infusion-related reactions and low white blood cell counts.
The most common side effects seen with GAZYVA in a study that included relapsed or refractory NHL, including FL patients were infusion-related reactions, fatigue, low white blood cell counts, cough, upper respiratory tract infection, and joint or muscle pain.
The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation and diarrhea.
The most common side effects of GAZYVA in LN were upper respiratory tract infection, COVID-19, urinary tract infection, bronchitis, pneumonia, infusion-related reactions, and neutropenia.
Before receiving GAZYVA, patients should talk to their doctor about:
- Immunizations: Before receiving GAZYVA therapy, the patient should tell their healthcare provider if they have recently received or are scheduled to receive a vaccine. Patients who are treated with GAZYVA should not receive live vaccines
- Pregnancy: The patient should tell their doctor if they are pregnant, think that they might be pregnant, plan to become pregnant, or are breastfeeding. GAZYVA may harm their unborn baby. The patient should speak to their doctor about using GAZYVA while they are pregnant. The patient should talk to their doctor or their child’s doctor about the safety and timing of live virus vaccinations to their infant if they received GAZYVA during pregnancy. Women of childbearing potential should use effective contraception while taking GAZYVA and for 6 months after your GAZYVA treatment
- Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, patients should not breastfeed while taking GAZYVA and for 6 months after your last dose
Patients should tell their doctor about any side effects.
These are not all of the possible side effects of GAZYVA. For more information, patients should ask their doctor or pharmacist.
GAZYVA is available by prescription only.
Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.
Please visit https://www.GAZYVA.com for the GAZYVA full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
About Genentech in Immunology
Genentech is committed to harnessing pioneering science and innovation to address critical unmet needs for patients with immune-mediated diseases. Our pipeline includes over a dozen clinical programs in immunology aiming to transform care for people living with lupus, MASH, ulcerative colitis, Crohn’s disease, immunoglobulin A nephropathy, idiopathic nephrotic syndrome, atopic dermatitis, and rheumatoid arthritis. We are investing end-to-end in immunology from discovery to R&D to commercialization across a variety of modalities including monoclonal antibodies, bispecifics, and CAR-T cell therapies to help solve some of the most difficult challenges in immunology today.
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.
Contacts
Media Contact: Nicolette Baker (858) 335-6516
Advocacy Contact: Meg Harrison (617) 694-7060
Investor Contacts: Loren Kalm (650) 225-3217
Bruno Eschli +41 61 687 5284
