Vididencel received fast track designation from the U.S. FDA

On September 8, 2023, vididencel, an off-the-shelf, intradermal vaccine, received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with acute myeloid leukemia (AML) in complete remission (CR) with residual disease.¹ Vididencel was also previously granted orphan drug designation for the treatment of patients with AML in the U.S. and Europe.¹

This fast track designation is based on results from the phase II ADVANCE II trial (NCT03697707) assessing vididencel monotherapy as a maintenance therapy for patients with AML in CR following chemotherapy, but with measurable residual disease (MRD).^1,2 Results demonstrated that vididencel has the potential to control MRD and induce durable relapse-free survival.¹ Vididencel will also be evaluated in combination with oral azacitidine in an upcoming phase II trial.¹