On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its supplemental Biologics License Application for EPKINLY® (epcoritamab) for the treatment of Adult Relapsed or Refractory Follicular Lymphoma (R/R FL). Priority review will decrease the review time to six months, compared to a standard 10 months. If approved by the FDA, EPKINLY® will be the first and only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy.
On 25 September 2023, AbbVie announced that its Tepkinly® (epcoritamab) received conditional marketing authorisation to Treat R/R DLBCL from the European Commission.