Epkinly designated as an orphan drug in Korea
By Eo, Yun-Ho | translator Kim, Jung-Ju
23.06.18 16:27:20
Simultaneous binding to CD3 on T cells and CD20 on B cells
Phase 1/2 EPCORE NHL-1 study achieves ORR of 61%
Epkinly, the first bispecific antibody drug involving T cells, has been designated as an orphan drug in Korea. The Ministry of Food and Drug Safety recently announced that it designated AbbVie's lymphoma treatment Epkinly as an orphan drug. The specific indication is relapsed or refractory DLBCL with a history of two or more systemic therapies. Epkinly is a type of immunoglobulin 1 bispecific antibody that simultaneously binds to CD3 of T cells and CD20 of B cells and induces T cell-mediated killing of lymphoma B cells. Recently, the US FDA obtained approval through the rapid approval program, and the phase 1/2 EPCORE NHL-1 study became the basis for approval.
The study enrolled 148 patients with CD20-p
Eo, Yun-Ho(unkindfish@dailypharm.com)