OnCo
drugsProductApproved2013🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Obinutuzumab

Obinutuzumab is a supercharged CD20 antibody that, paired with venetoclax for one year, gives many CLL patients years off all treatment.

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.

Schematic of the modality · Monoclonal antibody (anti-CD20, glycoengineered type II) · not a molecule; see the Monoclonal antibodies page
Mechanism, step by step
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1.Obinutuzumab binds CD20 in a type II orientation

Modality
Monoclonal antibody (anti-CD20, glycoengineered type II)
Mechanism
Type II anti-CD20 with afucosylated Fc: strong ADCC and direct, caspase-independent cell death; less CDC than rituximab.
Brand / code
Gazyva
Dosing & schedule
Route
IV
Schedule
Cycle 1: 100 mg day 1, 900 mg day 2, 1000 mg days 8 and 15; then 1000 mg day 1 of cycles 2-6 (with venetoclax from cycle 1 day 22 for 12 cycles total)
Monitoring
Infusion reactions (premedicate), HBV reactivation (boxed), PML (boxed), TLS, neutropenia

Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

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.

Commercial insurance
covered with prior authorisation

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.

Assistance programmes

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.

NICE recommendedNICE TA343 · 2015SMC: accepted
Appraised for
With chlorambucil for untreated CLL unsuitable for fludarabine-based therapy
Notes
Rituximab-refractory follicular lymphoma with bendamustine: TA472 (2017). Untreated advanced follicular lymphoma: TA513 (2018). With venetoclax for CLL: TA663 (2020).
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA343 · SMC advice: obinutuzumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2013Previously untreated CLL with chlorambucil (CLL11)
US2019Previously untreated CLL with venetoclax, fixed duration (CLL14); with acalabrutinib (ELEVATE-TN)

Safety

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Toxicity profile
Adverse eventAny gradeGrade 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.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
272 studies32 recruiting82 Phase 219 Phase 3
Search “Obinutuzumab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Obinutuzumab
intervention: Obinutuzumab
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Key papers

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rctNew England Journal of Medicine 2025changed practice
AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients

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.

rctThe Lancet 2020changed practice
ELEVATE-TN: acalabrutinib, alone or with obinutuzumab, against chemo-immunotherapy in untreated CLL

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.

rctNew England Journal of Medicine 2019changed practice
CLL14: one year of venetoclax plus obinutuzumab instead of chemo-immunotherapy in older, less fit CLL patients

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.

Latest papers

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Literature trend165 papers in the last 12 months+32% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

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