FDA Approves EPKINLY — Genmab US, Inc.

Genmab US, Inc. received FDA approval on May 19, 2023, for EPKINLY (epcoritamab-bysp), a bispecific CD3xCD20 antibody administered subcutaneously, which may broaden access compared to intravenous delivery methods. This launch positions Genmab to capitalize on the growing immuno-oncology market, particularly in treating diffuse large B-cell lymphoma, following the recent biosimilar entry from Pfizer.