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MAY 22, 2023

Epkinly Approved for Relapsed/Refractory Diffuse Large B-cell Lymphoma and High-Grade B-Cell Lymphoma

The FDA granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab) for relapsed/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.

Epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager, was evaluated in EPCORE NHL-1 (ClinicalTrials.gov Identifier: NCT03625037), an open-label, multi-cohort, multicenter, single-arm trial in patients