Gazyvaro (Obinutuzumab)

Monoclonal antibody for chronic lymphocytic leukemia, follicular lymphoma, and lupus nephritis

Rx – Prescription Only ATC: L01FA03 Anti-CD20 Monoclonal Antibody
Active Ingredient
Obinutuzumab
Form
Concentrate for solution for infusion
Strength
1000 mg/40 mL
Brand Names
Gazyvaro, Gazyva
Manufacturer
Roche Pharma AG
Administration
Intravenous infusion
Medically reviewed | Last reviewed: | Evidence level: 1A
Gazyvaro (obinutuzumab) is a type II anti-CD20 monoclonal antibody administered by intravenous infusion for the treatment of chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and lupus nephritis (SLE nephritis) in adults. It works by targeting a protein called CD20 on the surface of B-lymphocytes, leading to their destruction. Gazyvaro is always given under medical supervision in a hospital or clinic and requires pre-medications to reduce the risk of serious infusion-related reactions.
📅 Published:
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Written and reviewed by iMedic Medical Editorial Team | Specialists in oncology and hematology

Quick Facts About Gazyvaro

Active Ingredient
Obinutuzumab
Anti-CD20 antibody
Drug Class
Monoclonal Ab
Type II anti-CD20
ATC Code
L01FA03
Antineoplastic
Main Uses
CLL, FL, SLE
Blood cancers & lupus nephritis
Available Form
IV Infusion
1000 mg/40 mL vial
Prescription Status
Rx Only
Hospital administration

Key Takeaways About Gazyvaro

  • Hospital-only medication: Gazyvaro is given as an intravenous infusion under close medical supervision, never at home
  • Three approved indications: Used for chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and lupus nephritis in adults
  • Infusion reactions are common: Pre-medications (corticosteroids, antipyretics, antihistamines) are mandatory before each infusion to reduce reaction risk
  • Increased infection risk: Gazyvaro lowers B-cell counts, which can increase susceptibility to infections during and after treatment
  • Not for children: Gazyvaro is approved only for adults aged 18 years and over; safety and efficacy in children have not been established

What Is Gazyvaro and What Is It Used For?

Gazyvaro (obinutuzumab) is a monoclonal antibody that targets the CD20 protein on B-lymphocytes. It is used in adults for the treatment of chronic lymphocytic leukemia (CLL) in combination with chlorambucil, follicular lymphoma (FL) in combination with chemotherapy, and lupus nephritis (SLE nephritis) in combination with mycophenolate mofetil (MMF).

Gazyvaro belongs to a class of medicines known as monoclonal antibodies. These are laboratory-made proteins designed to recognize and attach to specific targets in the body. Obinutuzumab, the active ingredient in Gazyvaro, binds to a protein called CD20, which is found on the surface of B-lymphocytes — a type of white blood cell that plays an important role in the immune system.

When obinutuzumab attaches to CD20, it triggers a series of events that lead to the destruction of B-lymphocytes. This occurs through multiple mechanisms, including antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and direct induction of cell death. As a type II anti-CD20 antibody, Gazyvaro induces more direct cell death compared to type I anti-CD20 antibodies such as rituximab, which may contribute to its clinical effectiveness.

Chronic Lymphocytic Leukemia (CLL)

Gazyvaro is used for adults with previously untreated CLL who have other health conditions (comorbidities) that make it unlikely they could tolerate a full dose of fludarabin-based chemotherapy. In these patients, Gazyvaro is combined with chlorambucil, an oral chemotherapy agent. Clinical trials have demonstrated that the combination of Gazyvaro plus chlorambucil significantly improves progression-free survival compared to chlorambucil alone, and is also superior to rituximab plus chlorambucil.

Follicular Lymphoma (FL)

Follicular lymphoma is a type of non-Hodgkin lymphoma that develops from B-lymphocytes. Gazyvaro is approved for two FL populations:

  • Previously untreated FL: Gazyvaro is used in combination with chemotherapy (bendamustine, CHOP, or CVP) as initial treatment, followed by up to 2 years of maintenance therapy with Gazyvaro alone.
  • Relapsed or refractory FL: For patients who have received at least one prior treatment with rituximab and whose disease has returned or worsened, Gazyvaro is used in combination with bendamustine, followed by maintenance therapy.

In both settings, patients who respond to the initial treatment phase may continue to receive Gazyvaro as maintenance therapy every 2 months for up to 2 years or until disease progression, whichever comes first. The GALLIUM trial demonstrated that Gazyvaro-based chemoimmunotherapy significantly reduced the risk of disease progression compared to rituximab-based treatment in previously untreated FL.

Lupus Nephritis (SLE Nephritis)

Lupus nephritis is a serious complication of systemic lupus erythematosus (SLE) in which the body's immune system mistakenly attacks the kidneys. Gazyvaro is used in combination with mycophenolate mofetil (MMF) for the treatment of adults with active class III or IV lupus nephritis, with or without concurrent class V disease. By depleting B-lymphocytes, which contribute to the autoimmune process that damages the kidneys, Gazyvaro helps to slow or prevent further kidney damage. The NOBILITY trial showed that adding obinutuzumab to standard-of-care therapy improved complete renal response rates.

How Gazyvaro Differs From Rituximab

Both Gazyvaro and rituximab target CD20 on B-cells, but Gazyvaro is classified as a type II anti-CD20 antibody while rituximab is type I. This difference in antibody engineering means Gazyvaro induces greater direct cell death and enhanced antibody-dependent cellular cytotoxicity. Head-to-head clinical trials have shown Gazyvaro to be more effective than rituximab in CLL (CLL11 trial) and in previously untreated follicular lymphoma (GALLIUM trial).

What Should You Know Before Taking Gazyvaro?

Before starting Gazyvaro, your physician must evaluate your medical history, current medications, infection status, and vaccination needs. Gazyvaro is contraindicated in patients with known hypersensitivity to obinutuzumab. Special caution is needed for patients with prior infections, heart problems, or hepatitis B history.

Contraindications

You must not be treated with Gazyvaro if you are allergic to obinutuzumab or to any of the other ingredients in this medicine. The inactive ingredients include histidine, histidine hydrochloride monohydrate, trehalose dihydrate, poloxamer 188, and water for injections. If you are uncertain about any allergies, discuss this with your healthcare provider before treatment begins.

Warnings and Precautions

Speak with your doctor or nurse before being treated with Gazyvaro if any of the following apply to you:

  • You have an active infection, or have a history of long-lasting or recurrent infections
  • You have ever taken or received medicines that affect the immune system, such as chemotherapy or immunosuppressive drugs
  • You take any medication for high blood pressure or blood-thinning medication — your physician may need to adjust your treatment
  • You have ever had heart problems, including arrhythmias or heart failure
  • You have ever had neurological problems, such as memory issues, movement difficulties, or vision problems
  • You have ever had breathing or lung problems
  • You have ever had hepatitis B, a type of liver disease
Serious Warnings

Infusion-related reactions: These are the most common serious side effects and can occur during or up to 24 hours after infusion. Symptoms may include nausea, fatigue, dizziness, fever, chills, low blood pressure, breathing difficulties, and chest discomfort. The first infusion carries the highest risk.

Progressive Multifocal Leukoencephalopathy (PML): A very rare but life-threatening brain infection has been reported in patients treated with Gazyvaro. Seek immediate medical attention for memory loss, speech difficulties, trouble walking, or vision changes.

Tumor Lysis Syndrome (TLS): A potentially life-threatening complication that occurs when cancer cells break down rapidly, releasing their contents into the bloodstream. Preventive medications and hydration are given before treatment.

Hepatitis B Reactivation: Patients with a history of hepatitis B may experience reactivation of the virus during or after Gazyvaro treatment. Hepatitis B screening is required before starting therapy.

Vaccination is another important consideration. Some vaccines should not be given during Gazyvaro treatment or in the months following treatment. In particular, live vaccines must be avoided. Your doctor will check whether any vaccinations need to be administered before you start Gazyvaro, and will advise you on the appropriate timing for any vaccines you may need, for example before traveling abroad.

Pregnancy and Breastfeeding

Gazyvaro may pose risks during pregnancy. If you are pregnant, think you may be pregnant, or are planning to have a baby, inform your healthcare team before treatment. Your physician will help you weigh the benefits of continuing treatment against the potential risks to your baby. Obinutuzumab may cross the placental barrier and affect the developing fetus, particularly by depleting B-cells.

Breastfeeding: Do not breastfeed during treatment with Gazyvaro or for 18 months after your last dose, as small amounts of the medicine may pass into breast milk.

Contraception: Use effective contraception during treatment with Gazyvaro and continue using effective contraception for 18 months after your last dose. This precaution is important because of the potential effects of obinutuzumab on a developing fetus.

Children and Adolescents

Gazyvaro is not approved for use in children or adolescents under 18 years of age. There is no established safety or efficacy data in these age groups, and treatment should not be initiated in pediatric patients.

Driving and Operating Machinery

Gazyvaro is not expected to affect your ability to drive or use machines under normal circumstances. However, if you experience an infusion-related reaction during or after treatment, you should not drive, cycle, or operate machinery until the reaction has fully resolved.

How Does Gazyvaro Interact with Other Drugs?

Gazyvaro can interact with antihypertensive medications, anticoagulants, immunosuppressive drugs, and live vaccines. Tell your healthcare provider about all medications you take, including over-the-counter medicines and herbal products, before starting treatment.

Although formal drug interaction studies with obinutuzumab are limited due to its mechanism of action as a monoclonal antibody, several important interactions have been identified through clinical experience and pharmacological reasoning. Monoclonal antibodies are not metabolized by the cytochrome P450 enzyme system, so traditional drug-drug interactions are less likely. However, the following interactions are clinically significant:

Known and Potential Drug Interactions with Gazyvaro
Interacting Drug Type Clinical Significance Recommendation
Antihypertensive medications Major Increased risk of hypotension during infusion Consider withholding 12 hours before infusion and during the first hour after
Anticoagulants / Antiplatelets Major Increased bleeding risk due to Gazyvaro-induced thrombocytopenia Monitor platelet counts closely; dose adjustment may be necessary
Live vaccines Major Risk of vaccine-induced infection in immunocompromised patients Do not administer live vaccines during or after treatment until B-cell recovery
Inactivated vaccines Moderate Reduced immune response due to B-cell depletion Complete all needed vaccinations before starting treatment; response to vaccines during treatment may be diminished
Other immunosuppressants Moderate Additive immunosuppression; increased infection risk Monitor closely for signs of infection; prophylactic antimicrobials may be considered
Other anti-CD20 antibodies (e.g., rituximab) Moderate Prolonged B-cell depletion and hypogammaglobulinemia Avoid concurrent use; allow sufficient washout period between agents

Always inform your healthcare provider about all medicines you are currently taking or have recently taken, including prescription medicines, over-the-counter drugs, vitamins, and herbal supplements. This allows your medical team to monitor for potential interactions and adjust your treatment plan if necessary.

What Is the Correct Dosage of Gazyvaro?

Gazyvaro is given as an intravenous infusion at a dose of 1000 mg per administration. The dosing schedule varies depending on the condition being treated: 6 cycles for CLL, 6-8 induction cycles followed by maintenance for FL, and a specific schedule at weeks 0, 2, 24, 26 and then every 6 months for lupus nephritis.

Gazyvaro must be administered under the supervision of an experienced physician in a setting with immediate access to full resuscitation equipment. The standard dose is 1000 mg given as an intravenous infusion. Before each infusion, you will receive pre-medications to reduce the risk of infusion-related reactions and, in cancer indications, to reduce the risk of tumor lysis syndrome. These pre-medications may include intravenous corticosteroids, oral analgesics/antipyretics (such as paracetamol), antihistamines (such as diphenhydramine), and medications to prevent tumor lysis syndrome (such as allopurinol).

Dosage for Chronic Lymphocytic Leukemia (CLL)

For CLL, Gazyvaro is given in combination with chlorambucil over 6 treatment cycles of 28 days each. The first cycle requires a special split-dosing approach to minimize infusion-related reactions:

Gazyvaro Dosing Schedule for CLL
Cycle Treatment Day Dose Notes
Cycle 1 Day 1 100 mg Administered slowly over 4 hours at 25 mg/h; do not increase rate
Cycle 1 Day 2 (or continuation of Day 1) 900 mg Can be given on Day 1 if first 100 mg tolerated without infusion rate changes
Cycle 1 Day 8 1000 mg Full dose; infusion rate based on tolerance
Cycle 1 Day 15 1000 mg Full dose
Cycles 2–6 Day 1 1000 mg Full dose; single infusion per cycle

Chlorambucil is taken orally at a dose of 0.5 mg/kg body weight on days 1 and 15 of each treatment cycle. The total CLL treatment duration is six 28-day cycles, approximately 6 months.

Dosage for Follicular Lymphoma (FL)

For follicular lymphoma, treatment consists of an induction phase followed by a maintenance phase. During induction, Gazyvaro is combined with chemotherapy (bendamustine, CHOP, or CVP):

Gazyvaro Dosing Schedule for Follicular Lymphoma
Phase Cycle / Schedule Dose Notes
Induction – Cycle 1 Days 1, 8, and 15 1000 mg each Three doses in the first cycle
Induction – Cycles 2–6 (or 2–8) Day 1 of each cycle 1000 mg Cycle length is 28 days (bendamustine) or 21 days (CHOP/CVP)
Maintenance Every 2 months 1000 mg Up to 2 years or until disease progression

Patients who achieve a complete or partial response after induction may proceed to maintenance therapy. The shorter infusion time (approximately 90 minutes) may be used from cycle 2 onward for patients who did not experience grade 3 or higher infusion-related reactions during cycle 1.

Dosage for Lupus Nephritis (SLE Nephritis)

For lupus nephritis, Gazyvaro is given in combination with mycophenolate mofetil (MMF) according to a specific schedule:

Gazyvaro Dosing Schedule for Lupus Nephritis
Dose Number Treatment Timepoint Dose
Dose 1 Initial infusion 1000 mg
Dose 2 Week 2 (two weeks after dose 1) 1000 mg
Dose 3 Week 24 1000 mg
Dose 4 Week 26 (two weeks after dose 3) 1000 mg
Dose 5 and onward Every 6 months 1000 mg

Dose 5 should be administered 6 months after dose 4. Pre-medication with intravenous methylprednisolone (80 mg IV) is required for all patients with lupus nephritis. From dose 6 onward, intravenous corticosteroid pre-medication is only needed for patients who experienced an infusion-related reaction during the previous infusion.

Missed Dose

If you miss a scheduled Gazyvaro treatment, it is important to reschedule your appointment as soon as possible. Strict adherence to the dosing schedule is essential for optimal treatment effectiveness. Your healthcare team will adjust subsequent doses and timing to maintain the treatment schedule as closely as possible.

Infusion Rate Guidelines

The infusion rate of Gazyvaro is carefully managed to minimize the risk of infusion-related reactions. For CLL, the first dose (100 mg) is infused at 25 mg/hour and must not be increased. For subsequent infusions, the rate may be gradually escalated in increments of 50–100 mg/hour every 30 minutes, up to a maximum of 400 mg/hour, provided the patient tolerates it. For FL and lupus nephritis, the initial infusion starts at 50 mg/hour with similar escalation. If a patient experiences an infusion-related reaction, the infusion rate must be reduced or temporarily stopped.

What Are the Side Effects of Gazyvaro?

Like all medicines, Gazyvaro can cause side effects. The most common include infusion-related reactions (especially during the first infusion), fever, infections, low blood cell counts, fatigue, and gastrointestinal symptoms. Serious but rare side effects include PML, tumor lysis syndrome, and hepatitis B reactivation.

The side effect profile of Gazyvaro differs somewhat depending on whether it is used for blood cancers (CLL and FL) or for lupus nephritis. Below is a comprehensive overview of reported side effects organized by frequency for each indication.

Side Effects in CLL and Follicular Lymphoma

Very Common

Affects more than 1 in 10 patients
  • Infusion-related reactions (nausea, fatigue, dizziness, headache, fever, chills, vomiting, shortness of breath, flushing, low or high blood pressure, palpitations, chest discomfort)
  • Fever (pyrexia)
  • Lung infection (pneumonia)
  • Headache
  • Joint pain (arthralgia), back pain, limb pain
  • Feeling weak (asthenia) or tired (fatigue)
  • Diarrhea, constipation
  • Insomnia
  • Hair loss (alopecia), itching (pruritus)
  • Urinary tract infection, nasopharyngitis, shingles (herpes zoster)
  • Anemia (low red blood cells)
  • Low white blood cell counts (leukopenia, neutropenia)
  • Low platelet count (thrombocytopenia)
  • Upper respiratory tract infection, cough

Common

Affects 1 in 10 to 1 in 100 patients
  • Mouth sores (oral herpes)
  • Depression, anxiety
  • Influenza
  • Weight gain
  • Runny or stuffy nose
  • Eczema
  • Mouth or throat pain
  • Musculoskeletal chest pain
  • Skin cancer (squamous cell carcinoma, basal cell carcinoma)
  • Bone pain
  • Irregular heartbeat (atrial fibrillation)
  • Urinary problems, urinary incontinence
  • High blood pressure (hypertension)
  • Digestive problems (heartburn), hemorrhoids
  • Febrile neutropenia (fever with low neutrophil count)
  • Increased potassium, phosphate, or uric acid (tumor lysis syndrome markers)
  • Decreased potassium
  • Gastrointestinal perforation (in patients with GI involvement of cancer)

Uncommon

Affects 1 in 100 to 1 in 1,000 patients
  • Abnormal coagulation, including disseminated intravascular coagulation (DIC)
  • Low immunoglobulin levels (hypogammaglobulinemia)

Rare / Very Rare

Affects fewer than 1 in 1,000 patients
  • Progressive multifocal leukoencephalopathy (PML) — life-threatening brain infection
  • Hepatitis B reactivation

Side Effects in Lupus Nephritis

Patients treated with Gazyvaro for lupus nephritis may experience a somewhat different side effect profile due to the underlying autoimmune condition and the different co-medications used:

Very Common

Affects more than 1 in 10 patients
  • Bronchitis (inflammation of the airways)
  • Low immunoglobulin levels (hypogammaglobulinemia)
  • Infusion-related reactions

Common

Affects 1 in 10 to 1 in 100 patients
  • Pneumonia (lung infection)
  • Oral herpes (cold sores) or genital herpes
  • Neutropenia
When to Seek Immediate Medical Attention

Contact your healthcare provider or go to the emergency department immediately if you experience any of the following during or after Gazyvaro treatment:

  • Difficulty breathing, chest tightness, or wheezing
  • Severe dizziness or fainting
  • Sudden swelling of the face, tongue, or throat
  • Fever or chills with signs of infection (especially if persistent)
  • Memory loss, speech difficulties, trouble walking, or vision changes (possible PML symptoms)
  • Yellowing of the skin or eyes (possible hepatitis B reactivation)
  • Unusual bruising or bleeding

How Should You Store Gazyvaro?

Gazyvaro is stored and handled by healthcare professionals in the hospital or clinic. It must be refrigerated at 2°C–8°C, protected from light, and must not be frozen. Patients do not need to store this medicine at home.

Because Gazyvaro is an intravenous medication that is prepared and administered exclusively in clinical settings, you will not need to handle or store this medicine yourself. However, for reference, the storage conditions are as follows:

  • Storage temperature: Refrigerate at 2°C to 8°C (36°F to 46°F)
  • Do not freeze: Freezing can damage the protein structure of the antibody
  • Light protection: Keep in the original outer carton to protect from light
  • Shelf life: Use before the expiry date printed on the carton (EXP). The expiry date refers to the last day of that month
  • After dilution: The diluted solution is stable for 24 hours at 2°C–8°C followed by 48 hours (including infusion time) at temperatures up to 30°C when diluted in 0.9% sodium chloride
  • Disposal: Unused medicine and waste should be disposed of in accordance with local requirements for hazardous pharmaceutical waste

Keep all medicines out of the sight and reach of children. Your healthcare team at the hospital or clinic is responsible for proper storage and preparation of Gazyvaro before each infusion.

What Does Gazyvaro Contain?

Gazyvaro contains obinutuzumab as the active substance (1000 mg per 40 mL vial, concentration 25 mg/mL). It is supplied as a clear to slightly brownish liquid in a single-use glass vial, diluted in sodium chloride solution before intravenous infusion.

Active Substance

Each vial contains 1000 mg of obinutuzumab in 40 mL of concentrate, corresponding to a concentration of 25 mg/mL before dilution. Obinutuzumab is a glycoengineered, humanized type II anti-CD20 monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.

Inactive Ingredients (Excipients)

  • Histidine — buffer to maintain pH stability
  • Histidine hydrochloride monohydrate — buffer component
  • Trehalose dihydrate — stabilizer to protect the protein structure
  • Poloxamer 188 — surfactant to prevent protein aggregation
  • Water for injections — solvent

Appearance and Packaging

Gazyvaro is a clear to slightly brownish liquid supplied in a glass vial. Each carton contains 1 vial. Before administration, the concentrate is diluted in a PVC or PVC-free polyolefin infusion bag containing 0.9% sodium chloride solution. For the CLL first cycle (day 1), two separate bags are prepared: a 100 mL bag with 100 mg (4 mL concentrate) and a 250 mL bag with 900 mg (36 mL concentrate). For all other doses across all indications, 40 mL of concentrate is diluted in a 250 mL infusion bag.

Marketing Authorization Holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany. Gazyvaro is marketed as Gazyva in the United States and some other countries.

Frequently Asked Questions About Gazyvaro

Gazyvaro (obinutuzumab) is used in adults for three conditions: (1) previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil, for patients who cannot tolerate fludarabin-based chemotherapy; (2) follicular lymphoma (FL) in combination with chemotherapy, either as initial treatment or for patients whose disease returned after prior rituximab treatment; and (3) active lupus nephritis (class III or IV, with or without class V) in combination with mycophenolate mofetil. It works by targeting the CD20 protein on B-lymphocytes, leading to their destruction.

Gazyvaro is given as an intravenous (IV) infusion in a hospital or clinic under close medical supervision. The infusion takes several hours, with the rate carefully controlled and gradually increased if tolerated. Treatment duration depends on the condition: for CLL, 6 cycles over approximately 6 months; for FL, 6–8 induction cycles followed by maintenance every 2 months for up to 2 years; for lupus nephritis, initial doses at weeks 0, 2, 24, and 26, then every 6 months. Pre-medications are given before each infusion to reduce reaction risk.

The most serious side effects include: (1) Infusion-related reactions, which are most common during the first infusion and can range from mild symptoms like nausea and dizziness to severe reactions including breathing difficulties and low blood pressure; (2) Progressive multifocal leukoencephalopathy (PML), a very rare but life-threatening brain infection; (3) Tumor lysis syndrome, caused by rapid breakdown of cancer cells; (4) Hepatitis B reactivation in patients with prior infection; (5) Severe infections due to lowered immune defenses; and (6) Severe neutropenia, which increases infection risk. All patients should be closely monitored during and after treatment.

Both medicines target the same CD20 protein on B-cells, but they differ in important ways. Gazyvaro (obinutuzumab) is a type II anti-CD20 antibody, whereas rituximab is type I. This structural difference means Gazyvaro induces more direct B-cell death and enhanced antibody-dependent cellular cytotoxicity. In clinical trials, Gazyvaro has shown superior efficacy to rituximab in CLL (CLL11 trial) and previously untreated follicular lymphoma (GALLIUM trial), though both drugs remain important treatment options depending on the clinical context and patient factors.

Live vaccines must not be given during Gazyvaro treatment or for several months after the last dose, as the weakened immune system may not be able to fight off the live virus or bacteria in the vaccine. Inactivated vaccines can be given but may produce a reduced immune response due to B-cell depletion. Your doctor should review your vaccination status before starting treatment and ensure that any necessary vaccinations are completed well in advance. Discuss any planned vaccinations, including travel vaccines, with your healthcare team.

Women of childbearing potential should use effective contraception during Gazyvaro treatment and for at least 18 months after the last dose. This extended period reflects the long half-life of the antibody and the potential risk to a developing fetus. Breastfeeding should also be avoided during treatment and for 18 months after the final dose. If you become pregnant during treatment, contact your healthcare provider immediately so that the risks and benefits can be assessed.

References

  1. European Medicines Agency (EMA). Gazyvaro (obinutuzumab) — Summary of Product Characteristics. Last updated December 2025. Available at: www.ema.europa.eu/en/medicines/human/EPAR/gazyvaro
  2. Goede V, Fischer K, Busch R, et al. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014;370(12):1101-1110. doi:10.1056/NEJMoa1313984
  3. Marcus R, Davies A, Ando K, et al. Obinutuzumab for the first-line treatment of follicular lymphoma. N Engl J Med. 2017;377(14):1331-1344. doi:10.1056/NEJMoa1614598 (GALLIUM trial)
  4. Sehn LH, Chua N, Mayer J, et al. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-Hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncol. 2016;17(8):1081-1093.
  5. Furie RA, Aroca G, Cascino MD, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022;81(1):100-107. (NOBILITY trial)
  6. U.S. Food and Drug Administration (FDA). GAZYVA (obinutuzumab) Prescribing Information. Available at: FDA Drug Label
  7. World Health Organization (WHO). WHO Model List of Essential Medicines — 23rd List (2023). Geneva: WHO; 2023.
  8. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Version 2.2025.
  9. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 5.2025.

Editorial Team

This article was written and reviewed by the iMedic Medical Editorial Team, a multidisciplinary group of healthcare professionals specializing in oncology, hematology, clinical pharmacology, and medical writing.

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