The FDA has granted approval to epcoritamab-bysp (Epkinly), the first T-cell–engaging bispecific antibody, for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBCL). This approval comes after patients have undergone at least 2 lines of systemic therapies. The dosing regimen involves step-up dosing in cycle 1, followed by fixed weekly doses, every-other-week doses, and subsequent every-four-week doses.
The accelerated approval is supported by results from the EPCORE NHL-1 trial (NCT03625037), where epcoritamab achieved an overall response rate of 61% and a median duration of response of 15.6 months. With limited options available for patients with relapsed or refractory DLBCL, the approval of epcoritamab provides a valuable additional treatment option to improve outcomes.
