enmab announces regulatory updates from the U.S. FDA and European Medicines Agency for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously
- U.S. Food and Drug Administration grants Breakthrough Therapy Designation for epcoritamab-bysp for the treatment of relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
- European Medicines Agency validates regulatory application for epcoritamab for the same indication.
- The regulatory actions are supported by data from the phase 1/2 EPCORE NHL-1 trial.