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

Sep 11, 2023
Learning objective: After reading this article, learners will be able to cite a new development in AML.

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

  1. Mendus AB. Mendus receives U.S. FDA Fast Track Designation for vididencel in Acute Myeloid Leukemia (AML). Published Sept 8, 2023. Accessed Sept 11, 2023.
  2. Mendus AB. Mendus AB: Mendus presents positive survival data from the ADVANCE II trial evaluating DCP-001 as a maintenance therapy in AML at the American Society of Hematology (ASH) meeting. Published Dec 13, 2022. Accessed Sept 11, 2023.


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