Prescription medicine
Glofitamab Brand names: Columvi
Glofitamab (Columvi) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the glofitamab FDA label on DailyMed (effective June 25, 2026); every glofitamab label on DailyMed.
Highlights of the record
FDA label of June 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
CYTOKINE RELEASE SYNDROME.
Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.3 , and 2.4) and Warnings and Precautions (5.1) ]. WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity.
Used for
From the label: indications and usageCOLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
Forms and strengths
- 2.5 mg/2.5ml
- 10 mg/10ml
Solution (concentrate); concentrate.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,383 through July 30, 2026
What is glofitamab used for?
From the label: indications and usageCOLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). […]
Conditions named in the indications of glofitamab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Bispecific CD20-directed CD3 T Cell Engager.
Source: FDA drug label (Columvi), Genentech, Inc., effective June 25, 2026 (SPL set 3516e753-f064-4d30-9bd5-e3f2e143f75d), via openFDA; the full label on DailyMed
What does the patient leaflet for glofitamab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about COLUMVI?COLUMVI can cause serious side effects, including: Cytokine Release Syndrome (CRS). CRS is a serious side effect that is common during treatment with COLUMVI and can lead to death. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including: fever of 100.4°F (38°C) or higher chills or shaking fast or irregular heartbeat dizziness or light-headedness trouble breathing shortness of breath Due to the risk of CRS, you will receive COLUMVI on a "step-up dosing schedule". The "step-up dosing schedule" is when you receive smaller "step-up" doses of COLUMVI to help reduce your risk of CRS. You will receive a medicine called obinutuzumab on the first day of your first treatment cycle (Day 1 of Cycle 1). You will start the COLUMVI "step-up dosing schedule" a week after the obinutuzumab dose. You will receive smaller "step-up" doses of COLUMVI on Day 8 and Day 15 of Cycle 1. You will receive your first full dose of COLUMVI a week after the second "step-up" dose (this will be Day 1 of Cycle 2). Before each dose of COLUMVI, you will receive medicines to help reduce your risk of CRS and infusion-related reactions. You should be hospitalized during your infusion and for 24 hours: after receiving the first "step-up" dose on Day 8 of Cycle 1. after receiving the second "step-up dose" on Day 15 of Cycle 1, if you experienced CRS during the first "step-up" dose. if you had more than mild CRS with your previous dose of COLUMVI. If your dose of COLUMVI is delayed for any reason, you may need to repeat the "step-up dosing schedule". Your healthcare provider will monitor you for CRS during treatment with COLUMVI and may treat you in a hospital if you develop signs and symptoms of CRS. […]
From the patient leaflet: What should I avoid while receiving COLUMVI?Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems. See " What are the possible side effects of COLUMVI? " for more information about signs and symptoms of neurologic problems.
Source: FDA drug label (Columvi), Genentech, Inc., effective June 25, 2026 (SPL set 3516e753-f064-4d30-9bd5-e3f2e143f75d), via openFDA; the full label on DailyMed
Is there a generic for glofitamab (Columvi)?
No generic glofitamab is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for glofitamab?
The FDA Adverse Event Reporting System holds 2,383 reports that list glofitamab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 722 are coded as a death and 776 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as glofitamab?
36 other medicines are given the same way (intravenous) and in the same FDA class as glofitamab or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other bispecific cd20-directed cd3 t cell engagers
- the pharmacologic class, with prices and generics
- Glofitamab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other