Difference between revisions of "Epcoritamab (Epkinly)"

Revision as of 19:53, 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

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

References

@@ Line 8: / Line 8: @@
 *[[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]
 ==History of changes in FDA indication==