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COLUMVI (glofitamab-gxbm)

Prescribing Information
Medication Guide

Safety Data Sheets (MSDS)

COLUMVI™ Vials 2.5 mg/2.5 mL
COLUMVI™ Vials 10 mg/10 mL
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Product-Related Information

SAFETY INFORMATION

Study Design
Safety Profile
CRS Profile
CRS Management
Neurotoxicity Management
Abbreviations

The information in this section may include content beyond what is in the US Food and Drug Administration (FDA)-approved label. Because the FDA has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as a recommendation for use of a Genentech product for unapproved uses. For FDA-approved products, please consult the full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).

INDICATION: COLUMVI 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

WARNING: CYTOKINE RELEASE SYNDROME
See full prescribing information for complete boxed warning

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.

SAFETY INFORMATION

Study Design

Phase 1/2 Pivotal Trial of COLUMVI (glofitamab-gxbm) for Patients With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) After ≥2 Prior Lines of Therapy1,2

  • Open-label, multicenter, multicohort single-arm study
  • COLUMVI was administered as a fixed-duration treatment (12 cycles) with Cycle 1 step-up dosing to mitigate the risk of CRS
  • Obinutuzumab pretreatment was administered on C1D1 (7 days prior to COLUMVI initiation) to deplete circulating and lymphoid tissue B cells

Eligibility Criteria1,2

DLBCL Cohort Key Eligibility Criteria

Endpoints1-3

Primary Endpoint

  • Complete response (CR, best response) rate by IRCa

Key Secondary Endpoints

Study Treatment

  • Cycle 1, Day 1: Obinutuzumab 1000 mg pretreatment
  • Cycle 1, Day 8: COLUMVI 2.5 mg (step-up dose 1)
  • Cycle 1, Day 15: COLUMVI 10 mg (step-up dose 2)
  • Cycles 2-12, Day 1: COLUMVI 30 mg
  • Patients should be hospitalized during and for 24 hours after completion of the first step-up dose (2.5 mg dose on C1D8)
  • Patients who experienced any grade CRS during step-up dose 1 should be hospitalized during and for 24 hours after completion of step-up dose 2 (10 mg on C1D15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1
  • For subsequent doses, patients who experienced Grade ≥2 CRS with their previous infusion should be hospitalized during and for 24 hours after the completion of the next COLUMVI infusion

Footnotes

  1. By PET-CT (Lugano criteria).3
  2. By IRC and investigator.

References

  1. Dickinson MJ, et al. N Engl J Med. 2022;387(24):2220-2231.
  2. COLUMVI [prescribing information]. South San Francisco, CA: Genentech, Inc. 2023.
  3. Cheson BD, et al. J Clin Oncol. 2014;32(27):3059-3068.

Safety Profile

Safety Results1,2 (N=145)

  n (%)
Adverse reactions 143 (98.6%)
Grade 3-4 adverse reactions 85 (58.6%)
Serious adverse reactions 70 (48%)a
Fatal adverse reactions 8 (5.5%)b
Adverse reactions leading to permanent discontinuation of COLUMVI 10 (7%)c
Adverse reactions leading to dose interruptions of COLUMVI 27 (19%)d

Select Adverse Reactions1,e

Select adverse reactions (grouped and ungrouped terms) occurring in ≥10% of patients treated with COLUMVI (N=145)

Select Laboratory Abnormalities1,k

Laboratory abnormalities (≥20%) that worsened from baseline in patients treated with COLUMVI

Clinically relevant adverse reactions occurring in <10% of patients who received COLUMVI included infusion-related reaction, peripheral neuropathy, pneumonia, mental status changes, vomiting, tumor lysis syndrome, febrile neutropenia, upper respiratory tract infection, sepsis, herpes zoster infection, gastrointestinal hemorrhage, tremor, and myelitis.

Other Adverse Events of Interest1,2 (N=145)

  n (%)
Infections and infestations (all grades)
Grade 3-4
Grade 5		 57 (39.3%)
15 (10.3%)m
7 (4.8%)m
Neutropenia (all grades)
Grade ≥3		 55 (37.9%)
39 (26.9%)
Febrile neutropenia (all grades)
Grade ≥3		 5 (3.4%)
5 (3.4%)
Neurologic toxicity (all grades)
Grade ≥3		 58 (40.0%)n
3 (2.1%)o
Tumor flare events (all grades)
Grade ≥3		 17 (11.7%)
4 (2.8%)
ICANS (all grades)
Grade ≥3		 7 (4.8%)
2 (1.4%)

Footnotes

  1. Serious adverse reactions in ≥2% of patients included CRS, COVID-19 infection, sepsis, and tumor flare.
  2. COVID-19 infection (n=5; 3.4%), sepsis (n=2; 1.4%), and delirium (n=1; 0.6%).
  3. Includes infection, delirium, neutropenia, and CRS.
  4. Most frequently (≥2%) from neutropenia and thrombocytopenia.
  5. The figure includes a combination of grouped and ungrouped terms. Adverse reactions were graded using NCI CTCAE version 4.03, with the exception of CRS, which was graded per ASTCT consensus criteria in most cases.
  6. Includes musculoskeletal pain, back pain, bone pain, flank pain, myalgia, neck pain, and pain in extremity.
  7. Includes rash, rash pruritic, rash maculo-papular, dermatitis, dermatitis acneiform, dermatitis exfoliative, erythema, palmar erythema, pruritus, and rash erythematous.
  8. Includes fatigue and asthenia.
  9. Includes edema, edema peripheral, swelling face, and face edema.
  10. Includes abdominal pain, abdominal discomfort, and abdominal pain upper.
  11. The denominator used to calculate the rate varied from 137 to 145 based on the number of patients with a baseline value and at least one post-treatment value.
  12. Grade 4 neutrophil decrease occurred in 9% of patients.
  13. Grade 3 or higher infections reported in ≥2% of patients were COVID-19 infection (6%), including COVID-19 pneumonia, and sepsis (4.1%).
  14. The most frequent neurologic toxicities of any grade were headache (10%), peripheral neuropathy (8%), dizziness or vertigo (7%), and mental status changes (4.8%, including confusional state, cognitive disorder, disorientation, somnolence, and delirium).
  15. Grade 3 or higher neurologic adverse reactions occurred in 2.1% of patients and included somnolence, delirium, and myelitis.

References

  1. COLUMVI [prescribing information]. South San Francisco, CA: Genentech, Inc. 2023.
  2. Genentech Data on File.

CRS Profile

Incidence of CRS1,2,a (N=145)

CRS was predominantly Grade 1 and 2

Median Time to CRS Onset From Start of Infusion1,2

Median CRS Duration in Patients Treated with COLUMVI2

CRS by Cycle1,2,a

  • Recurrent CRS occurred in 34% of all patients
  • CRS can first occur with the 10 mg dose
    • Of 135 patients treated with the 10 mg dose of COLUMVI, 15 patients (11%) experienced their first CRS event with the 10 mg dose, of which 13 events were Grade 1, 1 event was Grade 2, and 1 event was Grade 3

CRS occurred predominantly in Cycles 1 and 2 and most events occurred after the C1D8 dose (the first dose of COLUMVI 2.5 mg)

CRS by Cycle in Patients Who Received Dexamethasone Premedication2

Limitations: No inference may be drawn from this data set.

Most Common Symptoms of Patients Who Experienced CRS1,2

Pyrexia
Tachycardia
Hypotension
Chills
Hypoxia

Footnotes

  1. Graded per ASTCT consensus criteria in most cases.
  2. ASTCT grading unavailable for ungraded events.

References

  1. COLUMVI [prescribing information]. South San Francisco, CA: Genentech, Inc. 2023.
  2. Genentech Data on File.

CRS Management

Monitoring for CRS1

Administer the COLUMVI infusions intravenously in a healthcare setting with immediate access to medical support to manage CRS, including severe CRS.

Cycle 1, Day 8

For the first COLUMVI step-up dose (2.5 mg on Cycle 1 Day 8), patients should be hospitalized during and for 24 hours after completion of the COLUMVI infusion

Cycle 1, Day 15

Patients who experienced any grade CRS during the first step-up dose (2.5 mg on Cycle 1 Day 8) should be hospitalized during and for 24 hours after completion of the second step-up dose (10 mg on Cycle 1 Day 15). CRS with step-up dose 2 can occur in patients who did not experience CRS with step-up dose 1a

Cycles 2-12, Day 1

For subsequent infusions (30 mg on Day 1 of Cycle 2 or subsequent cycles), patients who experienced Grade ≥2 CRS with their previous infusion should be hospitalized during and for 24 hours after completion of the next COLUMVI infusion

CRS Management per ASTCT 2019 Grading Criteria in the COLUMVI USPI1

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension.

If CRS is suspected, withhold COLUMVI and manage according to these recommendations and current practice guidelines. Administer supportive care for CRS, which may include intensive care for severe or life-threatening cases.

Grade 1

Presenting Symptomsb
Temperature ≥100.4°F (38° C)c

Actions

  • Withhold COLUMVI and manage per current practice guidelines
    • If symptoms resolve, restart infusion at a slower rated

For Next COLUMVI Dose

  • Ensure CRS symptoms are resolved for at least 72 hours before the next dosee
  • Consider slower infusion rate for next dose

Grade 2

Presenting Symptomsb
Temperature ≥100.4°F (38°C)c with

  • Hypotension not requiring vasopressors

and/or

  • Hypoxia requiring low-flow oxygenf by nasal cannula or blow-by

Actions

  • Withhold COLUMVI and manage per current practice guidelines
    • If symptoms resolve, restart infusion at a slower rated

For Next COLUMVI Dose

  • Ensure CRS symptoms are resolved for at least 72 hours before the next dosee
  • For the next dose, consider a slower infusion rate, monitor more frequently, and consider hospitalization
  • For recurrent Grade 2 CRS, manage per Grade 3 CRS

Grade 3

Presenting Symptomsb
Temperature ≥100.4°F (38°C)c with

  • Hypotension requiring a vasopressor (with or without vasopressin)

and/or

  • Hypoxia requiring high-flow oxygenf by nasal cannula, face mask, non-rebreather mask, or Venturi mask

Actions

  • Withhold COLUMVI and manage per current practice guidelines, which may include intensive care

For Next COLUMVI Dose

  • Ensure CRS symptoms are resolved for at least 72 hours before the next dosee
  • Hospitalize for the next dose of COLUMVI, monitor more frequently, and consider a slower infusion ratec
  • For recurrent Grade 3 CRS, permanently discontinue COLUMVI

Grade 4

Presenting Symptomsb
Temperature ≥100.4°F (38°C)c with

  • Hypotension requiring multiple vasopressors (excluding vasopressin)

and/or

  • Hypoxia requiring oxygen by positive pressure (eg, continuous positive airway pressure, bilevel positive airway pressure, intubation, and mechanical ventilation)

Actions

  • Permanently discontinue COLUMVI
  • Manage CRS per current practice guidelines, which may include intensive care

Footnotes

  1. Of 135 patients treated with the 10 mg dose of COLUMVI, 15 patients (11%) experienced their first CRS event with the 10 mg dose, of which 13 events were Grade 1, 1 event was Grade 2, and 1 event was Grade 3.
  2. American Society for Transplantation and Cellular Therapy (ASTCT) 2019 consensus grading criteria.
  3. Premedication may mask fever. Therefore, if clinical presentation is consistent with CRS, follow these management guidelines.
  4. Duration of infusion may be extended up to 8 hours, as appropriate for that cycle (see Table 1 of the COLUMVI PI).
  5. Refer to Table 2 of the COLUMVI PI for information on restarting COLUMVI after dose delays.
  6. Low-flow oxygen defined as oxygen delivered at <6 L/minute; high-flow oxygen defined as oxygen delivered at ≥6 L/minute.

Reference

  1. COLUMVI [prescribing information]. South San Francisco, CA: Genentech, Inc. 2023.

Neurotoxicity Management

Neurologic Toxicity (Including ICANS) Management in the COLUMVI USPI

At the first sign of neurologic toxicity, including ICANS, consider neurology evaluation and withholding COLUMVI based on the type and severity of neurotoxicity. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care.

Severitya,b

Grade 1

Actions

  • Continue COLUMVI and monitor neurologic toxicity symptoms
  • If ICANS, manage per current practice guidelines

Severitya,b

Grade 2

Actions

  • Withhold COLUMVI until neurologic toxicity symptoms improve to Grade 1 or baselinec,d
  • Provide supportive therapy and consider neurologic evaluation
  • If ICANS, manage per current practice guidelines

Severitya,b

Grade 3

Actions

  • Withhold COLUMVI until neurologic toxicity symptoms improve to Grade 1 or baseline for at least 7 daysd,e
  • For Grade 3 neurologic events lasting more than 7 days, consider permanently discontinuing COLUMVI
  • Provide supportive therapy and consider neurology evaluation
  • If ICANS, manage per current practice guidelines

Severitya,b

Grade 4

Actions

  • Permanently discontinue COLUMVI
  • Provide supportive therapy, which may include intensive care, and consider neurology evaluation
  • If ICANS, manage per current practice guidelines

Footnotes

  1. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.
  2. Based on ASTCT 2019 grading for ICANS.
  3. Consider the type of neurologic toxicity before deciding to withhold COLUMVI.
  4. See Section 2.2 Dosage and Administration of COLUMVI Prescribing Information on restarting COLUMVI after dose delays.
  5. Evaluate benefit-risk before restarting COLUMVI.

Reference

  1. COLUMVI [prescribing information]. South San Francisco, CA: Genentech, Inc. 2023.

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Publications and Congresses

The information in this section may include content beyond what is in the FDA-approved label. Because the FDA has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as recommendation for use of a Genentech product for unapproved uses. For FDA-approved products please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).

Publications: The list of publications is not an exhaustive list of published materials on the product. The list of references by data topics is selected per evidence-based medicine criteria. To browse a full listing of published scientific literature:

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Congresses: The list of congresses is a subset of Roche/Genentech posters and oral presentations for the product with data presented at scientific meetings in the recent 24 months. To browse full Roche/Genentech congress presentations and posters:

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  • AAAAI
    American Academy of Allergy Asthma & Immunology

  • AE
    Adverse event

  • Ang2
    Angiopoietin-2

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    Annualized Relapse Rate

  • ART
    Assisted Reproductive Technology

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    American Society for Transplantation and Cellular Therapy

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    Anti-thymocyte globulin

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    Chimeric antigen receptor

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    Cluster of differentiation 3

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    Cluster of differentiation 4

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    Confidence Interval

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    Coronavirus disease of 2019

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    Continuous positive airway pressure

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    Complete response

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    C-reactive protein

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    Cytokine release syndrome

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    Computed tomography

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    Common Terminology Criteria for Adverse Events

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    Disseminated intravascular coagulation

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    Diffuse large B-cell lymphoma

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    Disease-modifying therapy

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    Disease-modifying treatment

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    Duration of complete response

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    Duration of response

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    Double-blind, placebo-controlled food challenge

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    Eastern Cooperative Oncology Group performance status

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    European Medicines Association

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    Food and Drug Administration

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    US Food and Drug Administration

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    Follicular lymphoma

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    High-grade B-cell lymphoma

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    Hemophagocytic lymphohistiocytosis

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    Immune effector cell-associated neurotoxicity syndrome

  • ICU
    Intensive care unit

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    Immunoglobulin

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    Immunoglobulin E

  • IgG1
    Immunoglobulin G1

  • INR
    International normalized ratio

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    Independent Review Committee

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    Infusion-related reaction

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    Immunoreceptor tyrosine-based inhibitory motif

  • LLN
    Lower limit of normal

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    last menstrual cycle

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