Glofitamab-gxbm

(Columvi®)

Glofitamab-gxbm

Drug updated on 10/21/2024

Dosage FormInjection (intravenous; 2.5 mg/2.5 mL [1 mg/mL] in a single-dose vial, 10 mg/10 mL [1 mg/mL] in a single-dose vial)
Drug ClassCD20-directed CD3 T-cell engagers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.

Latest News

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Glofitamab demonstrated a 39% complete response (CR) rate (95% CI, 32 to 48) among 155 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including a 35% CR rate in the subgroup of 52 patients who had previously received CAR T-cell therapy.
  • The median time to achieve a complete response was 42 days (95% CI, 42 to 44), and 78% of those who achieved CR maintained it at 12 months. The 12-month progression-free survival (PFS) rate was 37% (95% CI, 28 to 46).
  • No direct comparative effectiveness data with other drugs were provided in the source.
  • Cytokine release syndrome (CRS) was the most common adverse event, occurring in 63% of patients, with 4% experiencing CRS of grade 3 or higher. Neurologic events of grade 3 or higher occurred in 3% of patients.
  • Adverse events of grade 3 or higher occurred in 62% of patients, and 9% of patients discontinued glofitamab due to adverse events.
  • The study focused on patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who had received at least two lines of previous therapy. Among the 52 patients who had previously received CAR T-cell therapy, the complete response rate was 35%, slightly lower than the overall response rate of 39%. No specific safety data for this subgroup were provided.

Product Monograph / Prescribing Information

Document TitleYearSource
Columvi (glofitamab-gxbm) Prescribing Information.2023Genentech Inc., South San Francisco, CA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Glofitamab for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
154Subjects
F: 35%
M: 65%
2022N Engl J Med

Sex Distribution:

F:35%
M:65%
154Subjects

Year:

2022

Source:N Engl J Med