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AbbVie Gets FDA Approval for Epkinly Combo for Relapsed Follicular Lymphoma
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AbbVie Gets FDA Approval for Epkinly Combo for Relapsed Follicular Lymphoma
Nov 18, 2025 5:41 PM

02:02 PM EST, 11/18/2025 (MT Newswires) -- AbbVie ( ABBV ) said the US Food and Drug Administration approved Epkinly in combination with rituximab and lenalidomide for adults with relapsed or refractory follicular lymphoma after at least one prior treatment.

The approval follows a Phase 3 trial, where the Epkinly-based regimen outperformed standard therapy, AbbVie ( ABBV ) said Tuesday in a statement.

AbbVie ( ABBV ) said 74% of patients achieved a complete response, and almost nine in 10 responded overall.

The combination reduced the risk of disease progression or death by 79%, the company said. Safety findings were consistent with known profiles, with low-grade cytokine release syndrome in 24% of patients and one case of low-grade neurotoxicity.

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