The U.S. Food and Drug Administration (FDA) has approved Epkinly (epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.


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Follicular lymphoma is a form of non-Hodgkin lymphoma characterized by a proliferation of B cells whose nodular structure of follicular architecture is preserved. Non-Hodgkin lymphoma is a cancer occuring in the lymphocytes.

Epcoritamab-bysp is a bispecific CD20-directed CD3 T-cell engager. The approval follows results from the EPCORE NHL-1 clinical study. The trial was an open-label, multi-cohort, multicenter, single-arm trial testing the efficacy and safety of the treatment. The primary outcome measures were overall response rate and duration of response. In the 127 patients enrolled, an overall response rate of 82% was observed, with 60% achieving complete responses. The duration of response estimate was not reached.

Prescribing information for epcoritamab includes a Boxed Warning for serious or fatal cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache.

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