FDA Approves Columvi (glofitamab) for Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Columvi is a bispecific CD20-directed CD3 T-cell engager. It binds to CD20 on B cells and CD3 on T cells, activating T cells to kill CD20-expressing B cells.

Columvi is indicated for 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.

Pretreat with a single 1,000 mg dose of obinutuzumab intravenously 7 days before initiation of Columvi (Cycle 1 Day 1). Administer premedications as recommended. Administer only as an intravenous infusion. Recommended dosage: Cycle 1 Day 8: step-up dose 1 (2.5 mg), Day 15: step-up dose 2 (10 mg); Cycles 2 to 12 Day 1: 30 mg. Each cycle is 21 days. Administer in a facility equipped to monitor and manage CRS. Patients should be hospitalized for the 2.5 mg step-up dose and for subsequent infusions as recommended.

Trial data not available in label.

Cytokine release syndrome (CRS) is a major risk. Patients should be hospitalized during and for 24 hours after step-up dose 1 (2.5 mg) and step-up dose 2 (10 mg) if any grade CRS occurred with step-up dose 1. For subsequent doses, hospitalization is recommended if prior infusion caused Grade ≥2 CRS. Ensure adequate hydration and premedicate before each dose.

Columvi is a treatment option for relapsed or refractory DLBCL or LBCL arising from follicular lymphoma after two or more prior systemic therapies. It is approved under accelerated approval; confirmatory trials are required to verify clinical benefit.