Posted by Michael Wonder on 28 Jun 2024
FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma
26 June 2024 - Today, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly, Genmab), a bispecific CD20 directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Efficacy and safety were evaluated in EPCORE NHL-1 (GCT3013-01), an open-label, multi-cohort, multi-centre, single-arm trial that included 127 patients with relapsed or refractory follicular lymphoma after at least two lines of systemic therapy.
