CORRECTING and REPLACING FDA Accepts Application for Genentech’s Gazyva for the Treatment of the Most Common Form of Lupus
- 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
The updated release reads:
FDA ACCEPTS APPLICATION FOR GENENTECH’S GAZYVA FOR THE TREATMENT OF THE MOST COMMON FORM OF LUPUS
- 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
“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
“For people living with SLE, the daily challenges of the disease can be both physically and emotionally overwhelming,” said
These data were simultaneously presented at the 15th European Lupus meeting, SLEuro 2026 and published in the
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
Data from the Phase III ALLEGORY study have also been used for a filing submission with the
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:
Patientsshould 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: Theseside 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
Please visit https://www.GAZYVA.com for the GAZYVA full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.
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