Monjuvi tafasitamab

Drug Class

CD19-directed monoclonal antibody

Mechanism

Binds CD19 expressed on pre-B and mature B lymphocytes, triggering ADCC and ADCP to eliminate neoplastic B-cells.

Approved Indication

In combination with lenalidomide, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

What This Means For Patients

Monjuvi (tafasitamab) is a CD19-targeting antibody used alongside lenalidomide to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL). It enhances immune cell pathways to engulf and destroy cancer cells. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2020) — label
• EMA — approved (2021) — source
• NMPA — approved (2024) — source

Pivotal Clinical Evidence

• L-MIND — Salles et al., Lancet Oncol 2020 (NCT02399085) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761163s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/minjuvi
• https://www.nmpa.gov.cn/