Epcoritamab Garners FDA Approval for FL Free

Genmab announced that the FDA has granted accelerated approval to epcoritamab (Epkinly) to treat patients with relapsed or refractory (r/r) follicular lymphomas (FL) who have tried at least two systemic therapies. The approval was based on the phase I/II EPCORE NHL-1 clinical trial, which involved 127 adults with r/r disease who had received a median of three therapies. The overall response rate was 82%, with a complete response rate of 60%; 67% of patients achieved minimal residual disease negativity (Lancet Haematol 2024 Jun 15 [Epub ahead of print]). After a median of 14.8 months, more than half of the patients continued to respond to epcoritamab, and the median duration of response was not reached. Epcoritamab is an off-the-shelf a bispecific CD20-directed CD3 T-cell engager.