Posted by Michael Wonder on 22 Oct 2019
BerGenBio receives FDA approval of fast track designation for bemcentinib
22 October 2019 - BerGenBio today announces that the U.S FDA has approved fast track designation for bemcentinib for the treatment of elderly patients with acute myeloid leukaemia whose disease has relapsed.
There are currently no marketed drugs specifically approved for all relapsed acute myeloid leukaemia (AML) patients, representing a significant unmet medical need.
BerGenBio has ongoing phase 2 trials in this indication and plans to seek regulatory advice from the FDA and EMA to determine the optimal regulatory path for bemcentinib in relapsed AML.
