19 May 2023 - Today, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab) 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.
Epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager, was evaluated in EPCORE NHL-1, an open-label, multi-cohort, multicenter, single-arm trial in patients with relapsed or refractory B-cell lymphoma.