EPKINLY® (Epcoritamab-bysp)

The FDA on November 18, 2025, approved EPKINLY® with Lenalidomide and Rituximab for relapsed or refractory Follicular Lymphoma (FL). The FDA also granted traditional approval to EPKINLY® as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (EPKINLY® was granted accelerated approval for this indication in 2024). Epkinly is a product of Genmab US, Inc.