Columvi

Diffuse large B-cell lymphoma (DLBCL) — relapsed or refractory, after two or more lines of systemic therapy

Pre-treatment: Obinutuzumab 1000 mg IV 7 days before Cycle 1
Cycle 1: Day 8: 2.5 mg IV, Day 15: 10 mg IV
Cycle 2-12: Day 1: 30 mg IV every 21 days
Fixed duration: Maximum 12 cycles
Pre-medication: Corticosteroid, antihistamine, acetaminophen before each dose during step-up and first full dose
Infusion time: 4 hours for first dose, 2 hours if prior infusion tolerated

Injection: 2.5 mg/2.5 mL and 10 mg/10 mL solution in single-dose vials

None listed.

• CRS: 44% (4% Grade ≥3). Most common during Cycle 1. Administer obinutuzumab pre-treatment to debulk and reduce CRS risk.
• Neurologic Toxicity: Including ICANS. 8% (3% Grade ≥3).
• Infections: 40% (16% Grade ≥3). Including COVID-19, bacterial, and fungal. Fatal infections reported.
• Cytopenias: Neutropenia 37% (Grade 3-4: 34%).
• Tumor Flare: May occur.

CRS (44%), musculoskeletal pain (28%), neutropenia (37%), fatigue (24%), rash (22%), infections (40%), diarrhea (14%), pyrexia (13%)

CRS in 46% (Grade 3 in 1.3%). Median onset 10 hours. Fatal and serious infections in 11% (including COVID-19, PML). Grade 3+ neutropenia in 24%.

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

CRS in 46% (Grade 3 in 1.3%). Median onset 10 hours. Fatal and serious infections in 11% (including COVID-19, PML). Grade 3+ neutropenia in 24%.

Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Glofitamab is a bispecific T-cell engaging antibody with a novel 2:1 molecular format — it has two binding domains for CD20 on B cells and one for CD3 on T cells. This 2:1 configuration provides bivalent binding to CD20, resulting in higher avidity for CD20-expressing tumor cells. Obinutuzumab pre-treatment depletes circulating B cells, reducing the risk of severe CRS during glofitamab step-up dosing.

Half-life: approximately 17 days at 30 mg target dose. Non-linear PK at lower step-up doses. Steady-state by Cycle 3. Clearance decreases with repeated dosing as CD20+ cells are depleted.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• NP30179 — Glofitamab in relapsed/refractory DLBCL after ≥2 prior therapies. Phase I/II, n=154.
  🔬 NCT03075696 ↗ 📄 Primary Publication ↗

Columvi has FDA-approved indications across the following cancer types covered on PipelineEvidence: