Difference between revisions of "Epcoritamab (Epkinly)"
Jump to navigation
Jump to search
m |
m |
||
| Line 4: | Line 4: | ||
<br>Extravasation: no information | <br>Extravasation: no information | ||
| − | == | + | ==Diseases for which it is used== |
| − | + | *[[Diffuse large B-cell lymphoma]] | |
| − | #''' | + | *[[High-grade B-cell lymphoma]] |
| + | *[[Transformed lymphoma]] | ||
| + | #'''EPCORE NHL-1:''' Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. Epub 2021 Sep 8. [https://doi.org/10.1016/s0140-6736(21)00889-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34508654/ PubMed] NCT03625037 | ||
##'''Update:''' Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. Epub 2022 Dec 22. [https://doi.org/10.1200/jco.22.01725 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc10115554/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/36548927/ PubMed] | ##'''Update:''' Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. Epub 2022 Dec 22. [https://doi.org/10.1200/jco.22.01725 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc10115554/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/36548927/ PubMed] | ||
| + | |||
| + | ==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)'' | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' GEN-3013 | *'''Code name:''' GEN-3013 | ||
| + | *'''Generic name:''' epcoritamab-bysp | ||
| + | *'''Brand name:''' Epkinly | ||
==References== | ==References== | ||
| Line 21: | Line 28: | ||
[[Category:Anti-CD3 antibodies]] | [[Category:Anti-CD3 antibodies]] | ||
| − | [[Category:Diffuse large B-cell lymphoma medications | + | [[Category:Diffuse large B-cell lymphoma medications]] |
| + | [[Category:High-grade B-cell lymphoma medications]] | ||
| + | [[Category:Transformed lymphoma medications]] | ||
| − | [[Category: | + | [[Category:FDA approved in 2023]] |
Revision as of 19:43, 19 May 2023
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
- EPCORE NHL-1: Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. Epub 2021 Sep 8. link to original article PubMed NCT03625037
- Update: Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. Epub 2022 Dec 22. link to original article link to PMC article PubMed
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)
Also known as
- Code name: GEN-3013
- Generic name: epcoritamab-bysp
- Brand name: Epkinly