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Columvi
Published
Product name
Columvi
Active ingredient
Glofitamab
Submission type
New Entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Columvi (glofitamab) was provisionally approved for the following therapeutic use:
Columvi monotherapy with obinutuzumab pretreatment has provisional approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Columvi is not indicated for the treatment of patients with primary central nervous system lymphoma.
The decision to approve this indication has been made on the basis of Complete Response and the Overall Response Rate from an uncontrolled, open label phase I/II study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
How this medicine works
Glofitamab is a bispecific monoclonal antibody that binds bivalently (with high avidity) to CD20 expressed on the surface of B cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T cells. By simultaneous binding to CD20 on the B cell and CD3 on the T cell, glofitamab mediates the formation of an immunological synapse with subsequent potent T-cell activation and proliferation, secretion of cytokines, and release of cytolytic proteins that results in the lysis of CD20-expressing B cells.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Columvi was considered favourable for the therapeutic use approved.
Sponsor