FDA Grants Accelerated Approval to Epcoritamab-bysp for Relapsed or Refractory DLBCL, High-Grade BCL

By Cecilia Brown - Last Updated: May 19, 2023

The US Food and Drug Administration (FDA) has granted accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, and high-grade B-cell lymphoma after two or more lines of systemic therapy. The approval includes DLBCL arising from indolent lymphoma.

The accelerated approval of the bispecific CD20-directed CD3 T-cell engager follows the FDA granting priority review to the Biologics License Application, which was submitted in fall 2022.

The therapy was evaluated in the single-arm EPCORE NHL-1 trial. The open-label, multicohort trial included 148 patients with relapsed or refractory DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma. The patients had relapsed or refractory disease after two or more lines of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy.

The overall response rate (ORR), which was the study’s main efficacy outcome measure, was 61%. More than one-third (38%) of patients achieved complete responses. The estimated duration of response was 15.6 months at a median follow-up of 9.8 months.

Prescribing information for epcoritamab-bysp includes a Boxed Warning for serious or life-threatening cytokine release syndrome and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome.

Source: US FDA, May 2023

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