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Glofitamab

Glofitamab is a fixed-duration bispecific for large B-cell lymphoma, with OS benefit when combined with chemotherapy.

Accelerated approval 2023 (ORR 56%, CR 43% in relapsed DLBCL after ≥2 lines). STARGLO showed OS benefit with GemOx in transplant-ineligible relapsed DLBCL (FDA declined in 2025 citing regional heterogeneity; approved in EU and elsewhere).

Loading structure…
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IgG antibody backbone (PDB 1IGT)
RCSB PDB

No public structure of glofitamab; representative IgG shown.

How it works, step by step · animated schematic, not to scale
T-cell engagers (bispecific)
Mechanism, step by step
auto-advancing · hover to pause

1.One arm binds CD20 (bivalent, 2:1 format) on the tumour cell

Modality
Bispecific T-cell engager (CD20×CD3, 2:1)
Mechanism
2:1 CD20:CD3 format with obinutuzumab pre-treatment to mitigate CRS.
Brand / code
Columvi
Dosing & schedule
Route
IV infusion
Schedule
Obinutuzumab 1,000 mg on cycle 1 day 1, then glofitamab 2.5 mg day 8, 10 mg day 15, then 30 mg every 3 weeks for up to 12 cycles (fixed duration)
Dose modifications
Hold for grade ≥2 CRS; dexamethasone premedication
Monitoring
Hospitalisation for the first 2.5 mg dose; CRS, neurology, infections

Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. 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. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting.

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 TA927 · 2023SMC: accepted
Appraised for
Relapsed or refractory DLBCL after 2 or more systemic treatments
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA927 · SMC advice: glofitamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 15 Jun 2023ApprovalUS

    Accelerated approval, relapsed/refractory DLBCL after ≥2 lines source

  2. Jul 2023ApprovalEU

    Conditional marketing authorisation source

  3. 2 Jul 2025Complete response letterUS

    Complete response letter for STARGLO combination (regional heterogeneity); approved in EU source

Approvals

RegionYearIndication
US2023Relapsed/refractory DLBCL after ≥2 lines (accelerated)

Safety

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Toxicity profile
Adverse event
Cytokine release syndrome
Neutropenia
Musculoskeletal pain
Rash
Fatigue
Infections
Tumour flare

Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part B (physician-administered); commercial plans per formulary
United KingdomNICE: recommended for relapsed/refractory DLBCL after ≥2 therapies (TA927)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
70 studies32 recruiting67 Phase 24 Phase 3
Search “Glofitamab” 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
Glofitamab
intervention: Glofitamab
Open on ClinicalTrials.gov →

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Key papers

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Latest papers

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Literature trend82 papers in the last 12 months+64% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Glofitamab" OR ABSTRACT:"Glofitamab" OR TITLE:"Columvi" OR ABSTRACT:"Columvi") 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 Glofitamab, not a curated reading list.

Connected

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