- Filing acceptance based on Phase III ALLEGORY data for Gazyva showing a significant reduction in disease activity compared with placebo in people with systemic lupus erythematosus (SLE)
- If approved, Gazyva would be the first anti-CD20 therapy to directly target B cells in SLE, potentially becoming the new standard of care for this condition
- SLE is a potentially life-threatening autoimmune disease affecting more than three million people worldwide – achieving better disease control can reduce flares and may prevent irreversible organ damage
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). The filing acceptance is based on positive results from the Phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint of SLE Responder Index 4 (SRI-4) at 52 weeks – a measure that assesses changes in disease severity, symptoms and physical condition. The FDA is expected to make a decision on an approval by December 2026. Gazyva is already approved for adults with lupus nephritis in the US and EU.
“The FDA’s sBLA acceptance for Gazyva brings us one step closer to providing a highly effective new treatment option for people living with this unpredictable and potentially life-threatening disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Gazyva may offer meaningful improvements in disease control and increase the likelihood of achieving complete remission in SLE while reducing the burden of long-term steroid use.”
“For people living with SLE, the daily challenges of the disease can be both physically and emotionally overwhelming,” said Albert T. Roy, president and CEO, Lupus Research Alliance. “We are hopeful for the approval of Gazyva as a new treatment for SLE — given its potential to manage symptoms as well as drive higher rates of clinical remission and reduce the frequency of debilitating flares.’’
These data were simultaneously presented at the 15th European Lupus meeting, SLEuro 2026 and published in the New England Journal of Medicine in March 2026.
The Phase III ALLEGORY results showed over three quarters (76.7%) of people treated with Gazyva plus standard therapy achieved a minimum four-point improvement in SRI-4 at 52 weeks, compared to 53.5% with placebo plus standard therapy (adjusted difference 23.1%, 95% confidence interval [CI]: 12.5-33.6, p<0.001). Safety was consistent with the well-characterized profile of Gazyva, and no new safety signals were identified.
Gazyva was also superior to placebo in all key secondary endpoints, and met additional secondary endpoints, including the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response at 52 weeks and glucocorticoid reduction to ≤7.5 mg/day, sustained from week 40 to 52. The study showed that people receiving Gazyva, plus standard therapy, were less likely to have a flare through to week 52, as defined by the British Isles Lupus Assessment Group (BILAG) index (Hazard ratio [HR]: 0.58, 95% CI: 0.40-0.82, p=0.002). A relevant finding as flares can lead to permanent organ damage. The median time to first flare could not be estimated. In addition, treatment with Gazyva plus standard therapy, versus placebo plus standard therapy, more than doubled the remission rate at 52 weeks (Definition of Remission in SLE (DORIS) - 33.8% versus 13.8%, adjusted difference 19.9%, 95% CI: 10.6-30.5). Lupus Low Level Disease Activity State (LLDAS) at 52 weeks also more than doubled with Gazyva compared to placebo (57.6% versus 25.0%, adjusted difference 32.6%, 95% CI: 22.3-43.0).
Data from the Phase III ALLEGORY study have also been used for a filing submission with the European Medicines Agency. ALLEGORY is one of four positive Phase III studies for Gazyva in immune-mediated diseases, in addition to REGENCY in lupus nephritis, INShore in idiopathic nephrotic syndrome and MAJESTY in primary membranous nephropathy. This growing body of evidence supports the potential of Gazyva to address disease activity across a spectrum of immune-mediated diseases. Beyond Gazyva, we have a broad pipeline as part of our ambition to bring breakthrough innovation to immunology, in particular in immune-mediated kidney and rheumatological diseases.
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 US and EU. Gazyva is also approved in 100 countries for various types of hematological cancers.
About the ALLEGORY Study
ALLEGORY [NCT04963296] is a Phase III, randomized, double-blind, placebo-controlled, multicenter study, investigating the efficacy and safety of Gazyva® (obinutuzumab) compared with placebo in adults with systemic lupus erythematosus (SLE) on standard therapy. The study enrolled approximately 300 people, who were randomized 1:1 to receive Gazyva or placebo for up to one year (52 weeks), followed by an open-label period with Gazyva for up to 104 weeks. The primary endpoint is the percentage of people who achieve SLE Responder Index four at week 52.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a potentially life-threatening autoimmune disease that affects more than three million people worldwide, and is rising. It is a chronic disease that causes inflammation in various parts of the body; for this reason it can affect multiple organ systems, especially the skin, joints and kidneys. As multiple organ systems are affected, it can cause varying symptoms, often taking two to six years for an accurate diagnosis. During this time, disease severity and organ damage, due to repeated flares of disease activity, typically worsens and quality of life declines.
Around half of people with SLE will develop lupus nephritis within five years of a lupus diagnosis. In lupus nephritis, the disease activity primarily affects the kidneys, posing a risk of kidney failure, where dialysis and transplant are the only treatment options.
There is a need for additional targeted therapies that can effectively control SLE disease activity and potentially delay or prevent the onset of lupus nephritis.
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 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: Kendall Tich (650) 467-6800
Advocacy Contact: Meg Harrison (617) 694-7060
Investor Contacts: Loren Kalm (650) 225-3217
Bruno Eschli +41 61 687 5284
