FDA approves Epkinly combo for follicular lymphoma indications
The US Food and Drug Administration today announced it has approved Danish biotech firm Genmab’s (Nasdaq: GMAB) Epkinly (epcoritamab-bysp) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL).
The FDA also granted traditional approval to epcoritamab-bysp as monotherapy for relapsed or refractory FL after two or more lines of systemic therapy (epcoritamab-bysp was granted accelerated approval for this indication in 2024).
In June last year, the FDA has approved Epkinly (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
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