Lunsumio mosunetuzumab

Drug Class

Bispecific CD20-directed CD3 T-cell engager

Mechanism

Dual-targets CD20 on B-cells and CD3 on T-cells, directing T-cells to execute immune-mediated cytolysis of malignant B-cells.

Approved Indication

Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

What This Means For Patients

Lunsumio (mosunetuzumab) is a bispecific monoclonal antibody indicated for patients with relapsed or refractory follicular lymphoma. It channels the body's native immune cells directly to the lymphoma cells to destroy them. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2022) — label
• EMA — approved (2022) — source
• NMPA — approved (2024) — source

Pivotal Clinical Evidence

• GO29781 — Budde et al., Lancet Oncol 2022 (NCT02500407) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761274s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/lunsumio
• https://www.nmpa.gov.cn/