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Epcoritamab: First Approval

delete2023-08-19
delete14
PRE
AI
J
James E. Frampton *
DOI:10.1007/s40265-023-01930-4delete
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摘要

摘要

En 中文
Epcoritamab (epcoritamab-bysp; Epkinly & TRADE;; Tepkinly(& REG;)) is a subcutaneously administered CD3xCD20 T-cell-engaging bispecific antibody being co-developed by Genmab and AbbVie for the treatment of mature B-cell non-Hodgkin lymphoma subtypes (B-NHLs), including diffuse large B-cell lymphoma (DLBCL). Epcoritamab received its first (conditional) approval on 19 May 2023, in the USA, for the treatment of adult patients with relapsed or refractory (R/R) DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after & GE; 2 lines of systemic therapy. Elsewhere, epcoritamab has received a positive opinion in the EU as a monotherapy for the treatment of adults with R/R DLBCL after & GE; 2 lines of systemic therapy, and is currently under regulatory review in Japan for the treatment of adults with R/R large B-cell lymphoma after & GE; 2 lines of systemic therapy. Clinical development of epcoritamab as monotherapy and in combination with standard of care agents for the treatment of mature B-NHLs is ongoing globally. This article summarizes the milestones in the development of epcoritamab leading to this first approval for R/R DLBCL.
Keyword:
LARGE B-CELL
RITUXIMAB PLUS LENALIDOMIDE
NON-HODGKIN-LYMPHOMA
SUBCUTANEOUS EPCORITAMAB
OPEN-LABEL
TRIAL
COMBINATION
MONOTHERAPY
SAFETY
R-2

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