Columvi glofitamab

Drug Class

Bispecific CD20-directed CD3 T-cell engager

Mechanism

Binds CD20 on B-cells and CD3 on T-cells, triggering T-cell activation and tumor cell cytolysis.

Approved Indication

Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.

What This Means For Patients

Columvi (glofitamab) is a bispecific monoclonal antibody that bridges cancer cells and healthy immune T-cells, enabling the immune system to actively eliminate lymphoma cells. It is clinically accessible in Boao Lecheng under the Hainan special-import policy.

Regulatory Approvals

• FDA — approved (2023) — label
• EMA — approved (2023) — source
• NMPA — approved (2023) — source

Pivotal Clinical Evidence

• NP30179 — Dickinson et al., N Engl J Med 2022 (NCT03075696) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/columvi
• https://www.nmpa.gov.cn/