Difference between revisions of "Epcoritamab (Epkinly)"
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==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
| + | *[[Follicular lymphoma]] | ||
*[[High-grade B-cell lymphoma]] | *[[High-grade B-cell lymphoma]] | ||
*[[Transformed lymphoma]] | *[[Transformed lymphoma]] | ||
| Line 11: | Line 12: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*2023-05-19: Granted accelerated approval for relapsed or refractory [[Diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL) not otherwise specified]], including [[Transformed lymphoma|DLBCL arising from indolent lymphoma]], and [[high-grade B-cell lymphoma]] after two or more lines of systemic therapy. ''(Based on EPCORE NHL-1)'' | *2023-05-19: Granted accelerated approval for relapsed or refractory [[Diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL) not otherwise specified]], including [[Transformed lymphoma|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-1)'' | ||
| + | |||
| + | ==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|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 B-cell lymphoma|primary mediastinal large B-cell lymphoma]]) or relapsed or refractory [[follicular lymphoma]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' GEN-3013 | *'''Code name:''' GEN-3013 | ||
*'''Generic name:''' epcoritamab-bysp | *'''Generic name:''' epcoritamab-bysp | ||
| − | *'''Brand | + | *'''Brand names:''' Epkinly, Tepkinly |
==References== | ==References== | ||
| Line 22: | Line 30: | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | [[Category:Anti-CD20 | + | [[Category:Anti-CD20-CD3 bispecific antibodies]] |
| − | |||
[[Category:Diffuse large B-cell lymphoma medications]] | [[Category:Diffuse large B-cell lymphoma medications]] | ||
| + | [[Category:Follicular lymphoma medications]] | ||
[[Category:High-grade B-cell lymphoma medications]] | [[Category:High-grade B-cell lymphoma medications]] | ||
[[Category:Transformed lymphoma medications]] | [[Category:Transformed lymphoma medications]] | ||
[[Category:FDA approved in 2023]] | [[Category:FDA approved in 2023]] | ||
| + | [[Category:EMA approved in 2023]] | ||
| + | [[Category:PMDA approved in 2023]] | ||
Latest revision as of 23:34, 26 June 2024
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-1)
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