The Food and Drug Administration announced it has approved epcoritamab-bysp, or Epkinly, marketed by Genmab (GMAB) US, with lenalidomide and rituximab for relapsed or refractory follicular lymphoma. The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy, noting that epcoritamab-bysp was granted accelerated approval for this indication in 2024.
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