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Obinutuzumab is a glycoengineered CD20 antibody that recruits immune cells and kills B cells more directly than rituximab. Paired with venetoclax for a fixed 12 months in chronic lymphocytic leukaemia, it keeps over half of patients treatment-free six years later, and it is also used in follicular lymphoma; first-dose infusion reactions are common and managed by splitting the dose.
Glycoengineered for enhanced ADCC and direct cell death. CLL11 (with chlorambucil, OS benefit vs rituximab-chlorambucil), CLL14 (venetoclax-obinutuzumab fixed 12 months: 6-year PFS 53% vs 22%), CLL13 (GIV triplet 5-year PFS 81%), ELEVATE-TN (with acalabrutinib, OS benefit). Also follicular lymphoma and (2024-25) lupus nephritis. Infusion reactions in the first dose are common and managed by split dosing.
Backbone ribbon from PDB 6Y97. RCSB PDB 6Y97. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Type II anti-CD20 with afucosylated Fc: strong ADCC and direct, caspase-independent cell death; less CDC than rituximab. Connects to CD20.
1.Obinutuzumab binds CD20 in a type II orientation
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA343 · SMC advice: obinutuzumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Region | Year | Indication |
|---|---|---|
| US | 2013 | Previously untreated CLL with chlorambucil (CLL11) |
| US | 2019 | Previously untreated CLL with venetoclax, fixed duration (CLL14); with acalabrutinib (ELEVATE-TN) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Infusion-related reactions CLL14 combination arm | 45% | 9% |
| Neutropenia with venetoclax | - | 53% |
| Infections | - | 18% |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
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AMPLIFY delivered the first all-oral, fixed-duration doublet for front-line CLL and supported its approval, giving fit patients a way to avoid both chemotherapy and years of continuous BTK inhibitor. It does not settle whether a doublet or triplet is best, or how AV compares with venetoclax-obinutuzumab. Patients with TP53 aberration were excluded and still need different strategies.
Evidence that the B-cell receptor pathway is worth attacking in follicular lymphoma when a Bruton tyrosine kinase inhibitor is paired with a type II CD20 antibody, after single-agent inhibitors had disappointed in this disease.
ELEVATE-TN put a more selective BTK inhibitor into first-line CLL and, with the head-to-head ELEVATE-RR trial, showed it is as effective as ibrutinib with fewer cardiac side effects. Continuous acalabrutinib became one of the two main front-line options alongside fixed-duration venetoclax combinations. The trade-off is indefinite therapy and cost versus a time-limited course.
CLL14 established the first chemotherapy-free, fixed-duration regimen for front-line CLL and made MRD-guided thinking mainstream in the disease. Patients get a year of treatment and then a treatment-free period rather than indefinite therapy. The choice today is between fixed-duration venetoclax combinations and continuous BTK inhibitors, with no proven survival difference.
Obinutuzumab-based immunochemotherapy is a first-line option for follicular lymphoma; the choice against rituximab weighs longer progression-free survival against toxicity and cost.
Rituximab remains the CD20 antibody used in first-line diffuse large B-cell lymphoma. The result is a warning against assuming an antibody improvement carries from one B-cell malignancy to another: the same substitution improved progression-free survival in chronic lymphocytic leukaemia and in follicular lymphoma.
Query for this drug: (TITLE:"Obinutuzumab" OR ABSTRACT:"Obinutuzumab" OR TITLE:"Gazyva" OR ABSTRACT:"Gazyva") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Obinutuzumab, not a curated reading list.
Shares Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma, A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies, A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treat, A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combi.
Shares A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies, A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas, Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one.
Shares ELEVATE-TN, GLOW, CELESTIAL-TNCLL, ROSEWOOD: a phase II randomized study of zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy in patients with relapsed or refractory follicular lymphoma.
Shares A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies, A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphom, CLL-IPI (chronic lymphocytic leukaemia prognostic index), CELESTIAL-TNCLL.
Shares GALLIUM: obinutuzumab for the first-line treatment of follicular lymphoma, A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory No, Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies, Ofatumumab.
Shares A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL), ELEVATE-TN, CLL-IPI (chronic lymphocytic leukaemia prognostic index).
Shares Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome, Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies, Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL), A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
Shares Venetoclax + obinutuzumab (12 months), GLOW, Michael Hallek, CELESTIAL-TNCLL.