EPKINLY epcoritamab

Drug Class

Bispecific CD20-directed CD3 T-cell engager

Mechanism

Binds CD20 on B-cells and CD3 on T-cells, inducing T-cell-mediated cytolytic activity against CD20-expressing lymphoma cells.

Approved Indication

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

What This Means For Patients

Epkinly (epcoritamab) is a bispecific monoclonal antibody designed for patients with advanced large B-cell lymphoma. It operates by binding directly to lymphoma cells and immune T-cells, enabling targeted immune destruction of tumors. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

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

Pivotal Clinical Evidence

• EPCORE NHL-1 — Thieblemont et al., J Clin Oncol 2023 (NCT03625037) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/tepkinly