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).
No public structure of glofitamab; representative IgG shown.
1.One arm binds CD20 (bivalent, 2:1 format) on the tumour cell
- 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
- 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
- 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.
- 15 Jun 2023ApprovalUS
Accelerated approval, relapsed/refractory DLBCL after ≥2 lines source
- Jul 2023ApprovalEU
Conditional marketing authorisation source
- 2 Jul 2025Complete response letterUS
Complete response letter for STARGLO combination (regional heterogeneity); approved in EU source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Relapsed/refractory DLBCL after ≥2 lines (accelerated) |
| 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.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | genentech-access.com |
| United Kingdom | NICE: recommended for relapsed/refractory DLBCL after ≥2 therapies (TA927) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductEpcoritamab
Shares Head-to-head bispecific vs CAR-T in second-line LBCL, Step-up dosing (T-cell engagers), EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, CD20.
- ProductOdronextamab
Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, CD20, CD3, T-cell engagers (bispecific).
- ProductMosunetuzumab
Shares EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, CD20, CD3, Roche / Genentech.
- TermB cell
Shares Lymphoma (tissue type), CD20, T-cell engagers (bispecific), Chronic lymphocytic leukaemia.
- ProductPirtobrutinib
Shares Richter transformation, Mantle cell lymphoma, Chronic lymphocytic leukaemia, Diffuse large B-cell lymphoma.
- ProductAxicabtagene ciloleucel
Shares Head-to-head bispecific vs CAR-T in second-line LBCL, LYSA – The Lymphoma Study Association, Lymphoma (tissue type), Diffuse large B-cell lymphoma.
- ProductTeclistamab
Shares Step-up dosing (T-cell engagers), IRCCS Azienda Ospedaliero-Universitaria di Bologna – Policlinico Sant'Orsola, CD3, T-cell engagers (bispecific).
- ProductRituximab
Shares CD20, Mantle cell lymphoma, Roche / Genentech, Chronic lymphocytic leukaemia.