COLUMVI

What it is

COLUMVI is available as a 2.5 mg or 10 mg concentrate for solution for infusion. It is a concentrate for intravenous infusion supplied as a preservative-free, colourless, clear solution in single-dose vials. Glofitamab is a bispecific monoclonal antibody that binds to CD20 expressed on the surface of B cells and to CD3 in the T-cell receptor complex expressed on the surface of T cells. By binding to both CD20 on B cells and CD3 on T cells, glofitamab mediates T-cell activation and proliferation, resulting in the lysis of CD20-expressing B cells. COLUMVI is subject to additional monitoring in Australia.

Approved indications

— COLUMVI monotherapy with obinutuzumab pretreatment for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy (provisional approval). — COLUMVI in combination with gemcitabine and oxaliplatin with obinutuzumab pretreatment for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are not candidates for autologous stem cell transplant (ASCT).

Dosing overview

COLUMVI dosing begins with a step-up schedule: 2.5 mg on Cycle 1 Day 8 over 4 hours, 10 mg on Cycle 1 Day 15, then 30 mg on Cycle 2 Day 1 and onwards. Each cycle is 21 days. All patients must receive a single 1000 mg dose of obinutuzumab 7 days prior to initiation of COLUMVI treatment to deplete circulating and lymphoid tissue B cells and thereby reduce the risk of cytokine release syndrome. No dose reductions of COLUMVI are recommended.

Key safety warnings

Cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) and including life-threatening reactions, occurred in patients receiving COLUMVI. A single dose of obinutuzumab must be administered 7 days prior to the initial dose of COLUMVI to reduce the risk of CRS. COLUMVI must not be administered to patients with active infection or inflammatory disorders. At least 1 dose of tocilizumab for use in the event of CRS must be available prior to COLUMVI infusion at Cycles 1 and 2, and access to an additional dose of tocilizumab within 8 hours of use of the previous tocilizumab dose must be ensured. Neurologic toxicity including ICANS has been reported in patients receiving COLUMVI, including serious and fatal reactions. Serious infections (including opportunistic infections) have occurred in patients treated with COLUMVI. Hepatitis B virus (HBV) reactivation can occur in patients treated with drugs directed against B cells, in some cases resulting in fulminant hepatitis, hepatic failure and death. Tumour lysis syndrome (TLS) has been reported in patients receiving COLUMVI, with patients at greater risk if they have high tumour burden, rapidly proliferative tumours, renal dysfunction, or dehydration.

Contraindications

COLUMVI is contraindicated in patients with a known hypersensitivity to glofitamab or any of the excipients.

PBS listing

COLUMVI 2.5 mg in 2.5 mL and 10 mg in 10 mL solutions for intravenous infusion are listed on the PBS with authority required restriction. The 2.5 mg strength has an ex-manufacturer price of A$1316.53. The 10 mg strength has an ex-manufacturer price of A$5266.10.

Regulatory history

COLUMVI was first registered on the ARTG on 9 August 2023 for both the 2.5 mg and 10 mg strengths. The monotherapy indication received provisional approval on the basis of Complete Response and Overall Response Rate from an uncontrolled, open-label phase I/II study, with continued approval dependent on verification and description of benefit in confirmatory trials. In July 2025, the PBAC recommended COLUMVI in combination with gemcitabine and oxaliplatin for relapsed or refractory DLBCL.