Epcoritamab (Epkinly)
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General information
Class/mechanism from the NCI Drug Dictionary: A bispecific monoclonal antibody, with potential immunomodulating and antineoplastic activities. Epcoritamab contains two antigen-recognition sites: one for human CD3, a T-cell surface antigen, and one for human CD20, a tumor-associated antigen (TAA) that is exclusively expressed on B cells during most stages of B-cell development and is often overexpressed in B-cell malignancies. Upon administration, epcoritamab binds to both T-cells and CD20-expressing B-lineage tumor cells. The resulting cross-linkage may trigger a potent cytotoxic T-lymphocyte (CTL) response against the CD20-expressing tumor B cells.
Route: IV
Extravasation: no information
Diseases for which it is used
History of changes in FDA indication
- 2023-05-19: Granted accelerated approval for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. (Based on EPCORE NHL-1)
- 2024-06-26: Granted accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma who received at least 2 prior lines of therapy. (Based on EPCORE NHL-1FL)
History of changes in EMA indication
- 2023-09-25: Granted conditional authorization at Tepkinly. Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
History of changes in PMDA indication
- 2023-09-25: Newly indicated for the treatment of relapsed or refractory large B-cell lymphoma (diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal large B-cell lymphoma) or relapsed or refractory follicular lymphoma.
Also known as
- Code name: GEN-3013
- Generic name: epcoritamab-bysp
- Brand names: Epkinly, Tepkinly