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.
1.Obinutuzumab binds CD20 in a type II orientation
- 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
- Genentech Access Solutions
- Genentech Patient Foundation — Free medicine for eligible patients regardless of insurance type.
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- 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.
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
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.
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.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductRituximab
Shares CLL13 / GAIA, ADCC (antibody-dependent cellular cytotoxicity), Complement in cancer, NK-cell recognition: missing self & stress ligands.
- TargetBCL-2
Shares GLOW, Venetoclax + obinutuzumab (12 months), CELESTIAL-TNCLL, AMPLIFY.
- TargetBTK (Bruton tyrosine kinase)
Shares ELEVATE-TN, GLOW, CELESTIAL-TNCLL, AMPLIFY.
- ProductAcalabrutinib
Shares ELEVATE-TN, AMPLIFY, ELEVATE-TN: acalabrutinib, alone or with obinutuzumab, against chemo-immunotherapy in untreated CLL, AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients.
- PairingBTK inhibitor + venetoclax, fixed duration
Shares GLOW, CELESTIAL-TNCLL, AMPLIFY, AMPLIFY: fixed-duration acalabrutinib plus venetoclax, with or without obinutuzumab, versus chemo-immunotherapy in fit CLL patients.
- ProductVenetoclax
Shares GLOW, Venetoclax + obinutuzumab (12 months), CELESTIAL-TNCLL, AMPLIFY.
- TermIGHV mutational status
Shares AMPLIFY, CLL13 / GAIA, CLL14: one year of venetoclax plus obinutuzumab instead of chemo-immunotherapy in older, less fit CLL patients, Chronic lymphocytic leukaemia.
- InstitutionUniversity Hospital Southampton / Centre for Cancer Immunology
Shares ADCC (antibody-dependent cellular cytotoxicity), CD20, Monoclonal antibodies, Chronic lymphocytic leukaemia.