FDA approves epcoritamab-bysp for follicular lymphoma indications

FDA

18 November 2025 - Today, the FDA approved epcoritamab-bysp (Epkinly, Genmab) 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 follicular lymphoma after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024).

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US , Registration