The FDA has approved a new drug called Columvi (glofitamab) for adults with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) that has come back or not responded to at least two prior treatments. This includes cases that started from follicular lymphoma. Columvi is a bispecific antibody that helps the immune system attack cancer cells. It is given by infusion into a vein using a step-up dosing schedule, and patients must first receive another drug (obinutuzumab) to reduce side effects. Because Columvi can cause a serious side effect called cytokine release syndrome (CRS), patients need to be hospitalized for the first dose and sometimes for later doses. This approval is under the FDA's accelerated pathway, meaning it is based on how well the drug shrinks tumors and how long that effect lasts. The company must still do more studies to confirm that Columvi helps patients live longer or feel better. If you or a loved one has DLBCL and has tried other treatments without success, talk to your doctor about whether Columvi might be an option. This approval offers hope for people who have few choices left, but it is important to understand the risks and benefits.
FDA approved Columvi (glofitamab) for Relapsed/Refractory Diffuse Large B-Cell LymphomaFDA approved new drug Columvi for adults with hard-to-treat lymphoma.
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The FDA has approved Columvi (glofitamab), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy. The approval is under accelerated approval based on response rate and durability of response. Continued approval may depend on verification of clinical benefit in confirmatory trials. Columvi is administered intravenously with a step-up dosing schedule and requires pretreatment with obinutuzumab to deplete B cells. Due to the risk of cytokine release syndrome (CRS), patients must be hospitalized for the first step-up dose and subsequent doses as recommended. This approval provides a new option for patients with limited treatment choices.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
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.
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