Posted by Michael Wonder on 08 Sep 2023
Mendus receives US FDA fast track designation for vididencel in acute myeloid leukaemia
8 September 2023 - Mendus today announced that it has received fast track designation from the US FDA for the Company’s lead program, vididencel, for the treatment of acute myeloid leukaemia in complete remission with residual disease.
The FDA’s decision was based on the previously communicated results from the ADVANCE II clinical trial, which delivered promising survival read-outs and underpinned the safety of vididencel as a monotherapy in acute myeloid leukaemia.
