AbbVie、Genmat赢得Epkinly在毛囊性淋巴瘤中的FDA标签扩展

2025-11-19 00:34

The U.S. Food and Drug Administration (FDA) on Tuesday announced the approval of Epkinly, a bispecific antibody developed by AbbVie (ABBV) and Genmab (GMAB) for follicular lymphoma, expanding its label further.
According to the FDA, Epkinly will now be available for relapsed or refractory follicular lymphoma with lenalidomide, a cancer drug from Bristol Myers (BMY), and a monoclonal antibody called rituximab from Biogen (BIIB) and Roche (OTCQX:RHHBY).
The agency also granted traditional approval for the injection as a late-line monotherapy option for relapsed or refractory FL, having granted its accelerated approval for Epkinly in this indication last year.
The approvals came with boxed warnings for safety concerns such as cytokine release syndrome linked to the treatment.
Previously, the FDA has approved Epkinly as a late-line agent for adults with R/R diffuse large B-cell lymphoma or FL.

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