Columvi (Glofitamab): Uses, Dosage & Side Effects
A bispecific monoclonal antibody for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults
Columvi (glofitamab) is a bispecific monoclonal antibody approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It works by simultaneously binding to CD20 on B cells and CD3 on T cells, redirecting the patient's own immune system to recognize and destroy lymphoma cells. Columvi can be given as monotherapy after two or more prior lines of treatment, or in combination with gemcitabine and oxaliplatin chemotherapy when stem cell transplantation is not feasible. It is administered as an intravenous infusion in a hospital setting under close medical supervision.
Quick Facts: Columvi
Key Takeaways
- Columvi (glofitamab) is the first bispecific CD20×CD3 T-cell engager approved for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), offering a new treatment option for patients who have not responded to prior therapies.
- Cytokine release syndrome (CRS) is the most significant risk; a step-up dosing schedule and obinutuzumab pretreatment are used to reduce its severity. Patients are monitored for at least 10 hours after the first infusion.
- Treatment consists of up to 12 fixed-duration 21-day cycles, making it a time-limited therapy unlike many continuous cancer treatments.
- Columvi can be used as monotherapy or in combination with gemcitabine and oxaliplatin, providing flexibility depending on transplant eligibility and prior treatment history.
- This medication must only be administered in a healthcare facility with access to resuscitation equipment and trained staff experienced in managing CRS and neurological toxicity.
What Is Columvi and What Is It Used For?
Columvi is a cancer immunotherapy medication containing the active substance glofitamab. It belongs to a novel class of therapeutics known as bispecific monoclonal antibodies, specifically designed to engage the patient's own T cells in the fight against cancer. Developed by Roche, Columvi received conditional marketing authorization from the European Medicines Agency (EMA) and accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma, accounting for approximately 30–40% of all newly diagnosed cases worldwide. It is an aggressive cancer that originates from B lymphocytes, a type of white blood cell that is part of the immune system. In DLBCL, these B cells grow and multiply uncontrollably, forming tumors in lymph nodes, bone marrow, the spleen, or other organs throughout the body. While many patients with DLBCL achieve remission with initial treatment (typically R-CHOP chemotherapy), approximately 30–40% will experience relapse or have disease that is refractory to first-line therapy.
Columvi is indicated in two clinical settings. As monotherapy, it is approved for adults whose DLBCL has relapsed or has been refractory after receiving two or more prior systemic therapies. In combination with gemcitabine and oxaliplatin (GemOx), it is approved for adults with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplantation. This dual indication provides oncologists with important therapeutic flexibility depending on the patient's treatment history, transplant eligibility, and clinical condition.
How Columvi Works
Glofitamab has a unique mechanism of action that distinguishes it from conventional monoclonal antibodies and chemotherapy agents. As a bispecific antibody, it is engineered to simultaneously bind to two different protein targets: CD20, a protein found on the surface of B cells (including malignant B cells in DLBCL), and CD3, a protein found on the surface of T cells (cytotoxic immune cells).
By binding to both targets at once, glofitamab acts as a molecular bridge that physically brings T cells into close proximity with CD20-expressing lymphoma cells. This direct engagement activates the T cells, triggering a cascade of immune responses including T-cell proliferation, release of cytotoxic granules (perforin and granzymes), and production of inflammatory cytokines. The result is targeted destruction of B cells, including the malignant B cells responsible for DLBCL. Importantly, this mechanism of action operates independently of the T cell's own T-cell receptor specificity, meaning that any T cell in the vicinity can be recruited to kill lymphoma cells.
A distinctive feature of Columvi's treatment protocol is the requirement for obinutuzumab pretreatment. Seven days before the first dose of Columvi, patients receive a single dose of obinutuzumab, an anti-CD20 monoclonal antibody. This pretreatment reduces the circulating B-cell population, which helps to mitigate the severity of cytokine release syndrome (CRS) that can occur when T cells are rapidly activated during the initial doses of glofitamab. The step-up dosing schedule used during the first cycle further minimizes this risk by gradually increasing the dose of Columvi.
The 2:1 molecular format of glofitamab, with two binding sites for CD20 and one for CD3, provides enhanced avidity for B-cell targets. This structural design allows for potent anti-tumor activity even on cells with lower CD20 expression levels, which can be clinically relevant in patients who have previously received anti-CD20 therapies such as rituximab.
What Should You Know Before Receiving Columvi?
Contraindications
Columvi must not be administered to patients who have a known allergy (hypersensitivity) to glofitamab or to any of the excipients contained in the formulation. Additionally, patients who are allergic to obinutuzumab, the anti-CD20 antibody given as pretreatment seven days before Columvi, must not receive this treatment regimen. If you have had allergic reactions to monoclonal antibody therapies in the past, discuss this thoroughly with your oncologist before starting treatment.
Warnings and Precautions
CRS is an excessive inflammatory response that can be life-threatening. It is most likely to occur during the first treatment cycle. Symptoms include fever, rapid heartbeat, low blood pressure, difficulty breathing, and multi-organ dysfunction. Seek immediate medical attention if you develop any of these symptoms. You will be closely monitored during and after infusions, and may receive premedication to reduce the risk.
Before receiving Columvi, tell your doctor if any of the following apply to you, as these may affect your treatment plan and require closer monitoring:
- Active infection: Any current infection, including bacterial, viral, or fungal infections, should be treated and resolved before starting Columvi. Your immune system will be significantly affected by the treatment.
- Chronic or recurrent infections: A history of long-term or frequently recurring infections may increase the risk of serious infections during treatment.
- Kidney, liver, or heart problems: Pre-existing organ impairment may affect how you tolerate the treatment and influence the management of potential complications such as CRS and tumor lysis syndrome.
- Planned vaccinations: Live vaccines should not be given during treatment with Columvi or for a period after treatment ends, as the medication affects B-cell populations and immune function. Discuss any planned vaccinations with your doctor.
Columvi can cause neurological side effects including confusion, disorientation, reduced consciousness, seizures, and difficulty speaking or writing. These symptoms can occur at any time during treatment. Tell your healthcare team immediately if you experience any neurological changes. Close monitoring is required, particularly during the first treatment cycles.
Tumor lysis syndrome (TLS) is another serious complication that can occur when cancer cells are destroyed rapidly, releasing their contents into the bloodstream. This can cause dangerously high levels of potassium, phosphate, and uric acid, and dangerously low levels of calcium. Your medical team will perform regular blood tests to monitor for TLS and may give you medications to reduce uric acid levels and ensure adequate hydration before each infusion.
Tumor flare reactions (tumor exacerbation) may occur during treatment with Columvi. These reactions can mimic disease progression and may present as tender or swollen lymph nodes, chest pain, difficulty breathing, or pain at tumor sites. Your oncologist will differentiate between true disease progression and tumor flare, which is generally a temporary reaction to the immune activation caused by the treatment.
Infections are a significant concern during Columvi treatment because the drug depletes B cells, which play a crucial role in immune defense. Patients may be at increased risk of bacterial, viral, and fungal infections. Your healthcare team will monitor you for signs of infection throughout treatment and may prescribe prophylactic antimicrobial medications. Report any signs of infection, such as fever, chills, cough, or burning sensation during urination, to your medical team promptly.
Pregnancy and Breastfeeding
Columvi should not be used during pregnancy. Based on its mechanism of action (B-cell depletion and T-cell activation), glofitamab has the potential to cause harm to the developing fetus. If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor before receiving this treatment. Women of childbearing potential must use effective contraception during treatment with Columvi and for at least 2 months after the last dose.
If you become pregnant during treatment, you must tell your doctor immediately. Your oncologist will discuss the potential risks and benefits with you and determine the most appropriate course of action for both your health and the pregnancy.
It is not known whether glofitamab is excreted in human breast milk. Given the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with Columvi and for at least 2 months after the last dose. Discuss the benefits and risks of breastfeeding with your healthcare provider.
Driving and Operating Machinery
Columvi may affect your ability to drive and use machines. Due to the risk of neurological effects (including confusion, disorientation, and seizures) and symptoms of CRS (such as dizziness and low blood pressure), you should not drive, cycle, or operate tools or machinery for at least 48 hours after each of your first two doses of Columvi. If you develop symptoms of ICANS or CRS at any point during treatment, avoid these activities until the symptoms have completely resolved. Consult your healthcare team before resuming driving or operating machinery.
Children and Adolescents
Columvi is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of glofitamab have not been studied in the pediatric population, and this medication should not be administered to patients below this age.
How Does Columvi Interact with Other Drugs?
As a bispecific monoclonal antibody, glofitamab is not metabolized by cytochrome P450 (CYP) enzymes or other common drug-metabolizing pathways. No formal pharmacokinetic drug interaction studies have been conducted with Columvi. However, there are several important clinical considerations regarding concomitant medications and the treatment protocol.
Treatment Protocol Medications
| Medication | Role | Clinical Details |
|---|---|---|
| Obinutuzumab | Mandatory pretreatment (Day 1 of Cycle 1) | Anti-CD20 antibody given 7 days before first Columvi dose to reduce B-cell counts and mitigate CRS risk. A single 1,000 mg IV dose is administered. |
| Corticosteroids (e.g., dexamethasone) | CRS premedication | Given 30–60 minutes before each Columvi infusion to reduce the incidence and severity of cytokine release syndrome. |
| Paracetamol (acetaminophen) | CRS premedication | Antipyretic given as part of the premedication regimen to manage fever associated with CRS. |
| Antihistamine (e.g., diphenhydramine) | CRS premedication | Given to reduce histamine-mediated symptoms during infusion and CRS episodes. |
| Gemcitabine + Oxaliplatin | Combination chemotherapy (optional) | Used in combination with Columvi for patients not eligible for stem cell transplantation. GemOx chemotherapy is given concurrently with Columvi infusions. |
Important Medication Considerations
Always inform your doctor, nurse, or pharmacist about all medications you are currently taking, have recently taken, or might take. This includes prescription medications, over-the-counter drugs, vitamins, and herbal supplements. While formal drug–drug interaction studies have not been conducted, the following considerations are clinically important:
- Live vaccines: Avoid live or live-attenuated vaccines during treatment with Columvi, as the medication causes B-cell depletion and immunosuppression. Inactivated vaccines may be less effective during treatment. Discuss vaccination timing with your oncologist.
- Immunosuppressive medications: The concurrent use of other immunosuppressive agents may increase the risk of infections. Your oncologist will carefully consider the risk–benefit ratio of any concomitant immunosuppressive therapy.
- CYP-mediated interactions: The initial release of cytokines during CRS may transiently suppress CYP enzyme activity. For patients receiving concomitant medications that are CYP substrates with narrow therapeutic indices (such as warfarin, cyclosporine, or certain anti-epileptic drugs), monitoring and dose adjustments may be necessary during the first treatment cycle.
Tocilizumab (an IL-6 receptor antagonist) is an important rescue medication used to treat moderate to severe CRS caused by Columvi. Ensure that at least two doses of tocilizumab are available at the treatment facility before starting Columvi infusions. Tocilizumab should be administered as per institutional CRS management protocols.
What Is the Correct Dosage of Columvi?
Columvi is administered exclusively by healthcare professionals experienced in cancer treatment, in a clinical setting with access to appropriate medical support for managing potential complications. The treatment follows a carefully designed step-up dosing schedule to minimize the risk of cytokine release syndrome (CRS) during the initial doses when T-cell activation is most intense.
Pretreatment
Obinutuzumab Pretreatment
Timing: 7 days before the first dose of Columvi (Cycle 1, Day 1)
Dose: Obinutuzumab 1,000 mg intravenous infusion
Purpose: Reduces circulating B-cell numbers to mitigate the severity of CRS when Columvi treatment begins
Premedication: 30–60 minutes before each Columvi infusion, patients may receive a corticosteroid (dexamethasone), an antipyretic (paracetamol), and an antihistamine (diphenhydramine) to further reduce CRS risk.
Dosing Schedule
| Cycle | Day | Dose | Notes |
|---|---|---|---|
| Cycle 1 | Day 1 | Obinutuzumab 1,000 mg | Pretreatment to reduce B cells |
| Cycle 1 | Day 8 | Columvi 2.5 mg | Step-up dose 1 (starting dose) |
| Cycle 1 | Day 15 | Columvi 10 mg | Step-up dose 2 (intermediate dose) |
| Cycles 2–12 | Day 1 | Columvi 30 mg | Full treatment dose every 21 days |
How Columvi Is Administered
Columvi is given as an intravenous (IV) infusion, meaning it is slowly dripped into a vein through a dedicated infusion line. The medication must never be administered as a rapid intravenous push or bolus injection. An infusion pump or syringe pump is used to control the infusion rate, and treatment may last up to 8 hours depending on the dose and the patient's tolerance.
The first infusion is typically administered over approximately 4 hours. When Columvi is given as monotherapy, patients are closely monitored during the first infusion and for 10 hours afterwards. When Columvi is given in combination with gemcitabine and oxaliplatin, post-infusion monitoring lasts for at least 4 hours after the first infusion. If moderate or severe CRS occurs, extended monitoring may be required for subsequent infusions. If no CRS has occurred after the first three doses, the infusion time for subsequent doses may be reduced to approximately 2 hours.
Missed Dose
If you miss a scheduled appointment for a Columvi infusion, contact your healthcare team immediately to reschedule. It is very important to receive all planned doses to achieve the full therapeutic benefit. Your oncologist will advise on the appropriate timing for the rescheduled dose based on where you are in the treatment cycle and how many doses have already been administered.
Dose Modifications and Treatment Discontinuation
Your doctor may need to temporarily pause, delay, or permanently discontinue Columvi treatment based on the occurrence and severity of side effects. Common reasons for dose modification include:
- CRS (Grade 2 or higher): Infusions are paused until CRS symptoms resolve, and appropriate supportive care (including tocilizumab and/or corticosteroids) is administered.
- ICANS: Treatment is held if neurological toxicity occurs and may be permanently discontinued for severe or recurrent events.
- Severe infections: Treatment is withheld until the infection is controlled.
- Severe cytopenias: Dose delays may be necessary for severe or prolonged neutropenia, thrombocytopenia, or other blood count abnormalities.
Do not stop treatment with Columvi without discussing it with your oncologist. Premature discontinuation may allow the lymphoma to progress. Your doctor will weigh the benefits and risks of continuing treatment at each cycle.
What Are the Side Effects of Columvi?
Like all cancer immunotherapies, Columvi can cause side effects, although not everyone experiences them. Due to its mechanism of action (T-cell activation and B-cell depletion), many of the side effects are related to immune activation or immunosuppression. The side effects listed below are organized by frequency based on clinical trial data. Report any new or worsening symptoms to your healthcare team immediately.
Contact your medical team immediately if you experience: fever or chills (possible CRS or infection), confusion or difficulty speaking (possible ICANS), rapid heartbeat or dizziness (possible CRS), difficulty breathing, severe muscle weakness, seizures, or unusual bleeding or bruising. These may indicate serious complications that require urgent treatment.
Columvi as Monotherapy
Very Common
- Cytokine release syndrome (CRS): Fever, rapid heartbeat, dizziness, nausea, headache, rash, confusion, chills, shortness of breath
- Tumor flare (tumor exacerbation): Tender or swollen lymph nodes, chest pain, difficulty breathing, pain at tumor sites
- Infections: Viral infections (including lung infections, shingles), bacterial infections
- Neutropenia: Low neutrophil count, which may cause fever or signs of infection
- Anemia: Low red blood cell count causing fatigue, weakness, and pale skin
- Thrombocytopenia: Low platelet count causing bruising or bleeding
- Fever (pyrexia)
- Electrolyte imbalances: Low phosphate, magnesium, calcium, or potassium levels (detected in blood tests)
- Skin rash
- Gastrointestinal: Constipation, diarrhea, nausea
- Headache
Common
- ICANS (neurotoxicity): Confusion, disorientation, reduced alertness, seizures, difficulty writing or speaking
- Tumor lysis syndrome: Weakness, shortness of breath, confusion, irregular heartbeat, muscle cramps
- Hyponatremia: Low sodium levels causing fatigue, muscle twitching, or cramps
- Elevated liver enzymes and bilirubin: May cause yellowing of skin or eyes and dark urine
- Serious infections: Bacterial infections, fungal infections, upper and lower respiratory tract infections, sepsis
- Lymphopenia: Low lymphocyte count affecting immune defense
- Febrile neutropenia: Fever with low neutrophil count
- Vomiting
- Gastrointestinal bleeding: May cause black stools or bloody vomiting
- Confusion, tremor, somnolence (drowsiness)
Uncommon
- Myelitis: Swelling of the spinal cord causing muscle weakness or numbness
- Colitis: Inflammation of the colon causing abdominal pain, bloody stools, and urgent bowel movements
Columvi in Combination with Chemotherapy (Gemcitabine + Oxaliplatin)
When Columvi is used in combination with gemcitabine and oxaliplatin, additional and sometimes more frequent side effects may occur due to the effects of the chemotherapy drugs.
Very Common
- Thrombocytopenia, neutropenia, anemia, lymphopenia (low blood cell counts)
- Cytokine release syndrome (CRS)
- Tumor flare reactions
- Peripheral neuropathy: Numbness, tingling, burning sensation, pain, or weakness in hands and feet (from oxaliplatin)
- Nausea, vomiting, diarrhea, constipation, abdominal pain
- Elevated liver enzymes (detected in blood tests)
- Skin rash, fever, musculoskeletal pain
- Hypokalemia, hyponatremia (low potassium and sodium)
- Infections: COVID-19, pneumonia, respiratory infections
Common
- ICANS (neurotoxicity), tumor lysis syndrome
- Headache
- Low magnesium, calcium, or phosphate
- Viral, bacterial, and fungal infections; sepsis
- Elevated bilirubin
- Febrile neutropenia
- Colitis: Inflammation of the colon
- Pancreatitis: Inflammation of the pancreas
- Pneumonitis: Inflammation of the lungs causing cough and breathing difficulties
Uncommon
- Tremor
- Hepatitis: Elevated liver enzymes indicating liver inflammation
- Pneumocystis jirovecii pneumonia (PJP): A type of opportunistic lung infection
It is important to report suspected side effects after the medication has been approved, as this enables continuous monitoring of its benefit–risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority (e.g., the MHRA Yellow Card scheme in the UK, FDA MedWatch in the US, or EudraVigilance in the EU).
How Should You Store Columvi?
Columvi is a hospital-administered medication, and storage is the responsibility of healthcare professionals. Patients do not need to store this medication at home. However, the following storage information is provided for completeness and for healthcare settings.
- Temperature: Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze the vials. If the solution has been frozen, do not use it.
- Light protection: Keep the vials in the original carton to protect them from light.
- Expiry date: Do not use after the expiry date printed on the carton and vial label (the expiry date refers to the last day of that month).
- Visual inspection: Columvi is a colorless, clear solution. Do not use the medication if it appears cloudy, discolored, or contains visible particles.
- Single-use vials: Each vial is intended for single use only. Discard any unused solution remaining in the vial after dose preparation.
Diluted Solution Stability
Once diluted for intravenous infusion, the prepared solution has demonstrated chemical and physical stability for a maximum of 72 hours at 2°C to 8°C, followed by 24 hours at up to 30°C, and a maximum infusion time of 8 hours. From a microbiological standpoint, the diluted solution should be used immediately unless prepared under controlled and validated aseptic conditions. If not used immediately, in-use storage times should not normally exceed 24 hours at 2°C to 8°C.
The diluted solution should be brought to room temperature (approximately 25°C) before the start of the intravenous infusion. Unused medication and waste should be disposed of in accordance with local regulations for cytotoxic/biohazardous materials.
What Does Columvi Contain?
Columvi is supplied as a concentrate for solution for infusion in single-use glass vials. Each package contains one vial. The formulation is designed for dilution with sodium chloride solution before intravenous administration.
Active Ingredient
Glofitamab is the active pharmaceutical ingredient in Columvi. It is a full-length humanized bispecific monoclonal antibody of the immunoglobulin G1 (IgG1) subclass, produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Two vial sizes are available:
- Columvi 2.5 mg: Each vial contains 2.5 mg of glofitamab in 2.5 ml of concentrate (concentration: 1 mg/ml)
- Columvi 10 mg: Each vial contains 10 mg of glofitamab in 10 ml of concentrate (concentration: 1 mg/ml)
Inactive Ingredients (Excipients)
The other ingredients in Columvi are:
- L-Histidine (buffer)
- L-Histidine hydrochloride monohydrate (buffer)
- L-Methionine (antioxidant stabilizer)
- Sucrose (stabilizer)
- Polysorbate 20 (E432) – surfactant
- Water for injections
This medicine contains 1.25 mg polysorbate 20 per 2.5 ml vial and 5 mg polysorbate 20 per 10 ml vial (equivalent to 0.5 mg/ml). Polysorbates can cause allergic reactions in some individuals. Inform your doctor if you have known allergies to polysorbates.
Dilution and Compatibility
Columvi must be diluted before administration using either sodium chloride 0.9% (normal saline) or sodium chloride 0.45% injection solution. No other diluents should be used. The final glofitamab concentration after dilution should be between 0.1 mg/ml and 0.6 mg/ml. The diluted solution is compatible with IV infusion bags made of polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), and polyolefin materials. In-line filtration is not required but may be used if desired (polyethersulfone or polysulfone membrane filters are compatible).
Frequently Asked Questions About Columvi
Columvi (glofitamab) is used to treat adults with diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive non-Hodgkin lymphoma. It is specifically indicated for patients whose cancer has relapsed (come back) or has been refractory (not responded) to prior treatment. As monotherapy, it is used after at least two prior systemic therapies. In combination with gemcitabine and oxaliplatin chemotherapy, it is used in patients who are not eligible for autologous stem cell transplantation.
Columvi is a bispecific monoclonal antibody that acts as a molecular bridge between the cancer cells and the patient's own immune cells. It binds simultaneously to CD20 (a protein on B cells, including cancer cells) and CD3 (a protein on T cells, the immune system's killer cells). By physically linking these two cell types, Columvi activates T cells and directs them to recognize and destroy CD20-positive lymphoma cells. This mechanism works independently of the T cell's natural target recognition, enabling a powerful and focused anti-cancer immune response.
Cytokine release syndrome (CRS) is a very common side effect of Columvi, affecting more than 1 in 10 patients. CRS occurs when the T cells activated by the drug release large amounts of inflammatory proteins (cytokines) into the bloodstream. Symptoms range from mild fever and chills to severe complications including low blood pressure, difficulty breathing, and multi-organ dysfunction. CRS is most likely during the first treatment cycle, which is why a step-up dosing schedule is used and patients are closely monitored. Premedication with corticosteroids, paracetamol, and antihistamines is given before each dose to reduce the risk and severity.
Columvi treatment consists of a maximum of 12 cycles, with each cycle lasting 21 days. The total treatment duration is therefore approximately 8 to 9 months if all 12 cycles are completed. The first cycle includes three infusion visits (obinutuzumab pretreatment on day 1, and Columvi on days 8 and 15), while subsequent cycles involve a single infusion on day 1. This fixed-duration treatment schedule is a notable advantage, as many other cancer immunotherapies are administered continuously until disease progression.
No, Columvi is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of glofitamab have not been studied in the pediatric population. Columvi is currently indicated exclusively for adult patients with relapsed or refractory diffuse large B-cell lymphoma. If a child or adolescent has DLBCL, their oncologist will recommend appropriate treatment options that have been evaluated in pediatric populations.
Columvi requires extensive monitoring throughout treatment. During the first infusion, patients are monitored for the entire infusion duration (approximately 4 hours) and for 10 hours afterwards when given as monotherapy, or 4 hours when given with chemotherapy. This is primarily to detect and manage cytokine release syndrome (CRS). Regular blood tests are performed to monitor blood cell counts (neutrophils, red blood cells, platelets), liver and kidney function, and electrolyte levels. Patients are also assessed for neurological symptoms (ICANS), signs of infection, and tumor lysis syndrome at each visit.
References
This article is based on current international regulatory documents, clinical trial data, and peer-reviewed oncology research. All sources meet evidence level 1A standards.
- European Medicines Agency (EMA). Columvi (glofitamab) – Summary of Product Characteristics. EMA/CHMP; 2025. Comprehensive regulatory document covering indications, dosing, contraindications, and safety data for the European Union.
- U.S. Food and Drug Administration (FDA). Columvi (glofitamab-gxbm) Prescribing Information. FDA; 2024. Full US prescribing information including boxed warnings for CRS and neurological toxicity.
- Dickinson MJ, Carlo-Stella C, Morschhauser F, et al. Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma. New England Journal of Medicine. 2022;387(24):2220-2231. doi:10.1056/NEJMoa2206913. Pivotal Phase II trial establishing efficacy and safety of glofitamab monotherapy.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 2.2025. Evidence-based treatment recommendations for DLBCL including bispecific antibody therapies.
- Tilly H, Morschhauser F, Sehn LH, et al. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. New England Journal of Medicine. 2022;386(4):351-363. doi:10.1056/NEJMoa2115304. Context on DLBCL treatment landscape.
- European Society for Medical Oncology (ESMO). Diffuse Large B-Cell Lymphoma: ESMO Clinical Practice Guidelines. Annals of Oncology. 2024. International guidelines for diagnosis, staging, and treatment of DLBCL.
- Lee DW, Santomasso BD, Locke FL, et al. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biology of Blood and Marrow Transplantation. 2019;25(4):625-638. doi:10.1016/j.bbmt.2018.12.758. Standard grading system for CRS and ICANS.
- Sehn LH, Salles G. Diffuse Large B-Cell Lymphoma. New England Journal of Medicine. 2021;384(9):842-858. doi:10.1056/NEJMra2027612. Comprehensive review of DLBCL pathogenesis, classification, and treatment.
- World Health Organization (WHO). WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 5th edition. Lyon: WHO; 2022. Definitive classification of lymphoma subtypes including DLBCL.
- Hutchings M, Morschhauser F, Iacoboni G, et al. Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma. Journal of Clinical Oncology. 2021;39(18):1959-1970. doi:10.1200/JCO.20.03175. Early phase clinical data supporting glofitamab development.
Editorial Team
This article has been written and reviewed by the iMedic medical editorial team according to our strict editorial standards. Our team includes licensed physicians, pharmacists, and medical researchers with expertise in oncology, hematology, and clinical pharmacology.
Content developed by iMedic's medical writing team based on current international guidelines (EMA, FDA, NCCN, ESMO) and peer-reviewed oncology research.
Independently reviewed and fact-checked by the iMedic Medical Review Board, comprising board-certified specialists in oncology, hematology, and clinical pharmacology.
All medical claims are supported by Level 1A evidence (systematic reviews, meta-analyses, and randomized controlled trials) following the GRADE evidence framework.
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