FDA Grants Accelerated Approval to EPKINLY®, First Bispecific Antibody for Relapsed/Refractory Follicular Lymphoma

Jun 26, 2024, 11:38 PM

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Epcoritamab, marketed as EPKINLY®, for the treatment of relapsed or refractory follicular lymphoma (R/R FL). This approval marks the second for EPKINLY® and makes it the first bispecific antibody approved for both R/R FL and relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) in the U.S. The drug is developed by AbbVie and Genmab, trading under the stock symbols $ABBV and $GMAB respectively. The approval has been highlighted in the #lymsm and #oncology communities.