FDA Lifts Clinical Hold on Vadastuximab Talirine Trials in AML

March 6, 2017 – The FDA has lifted its clinical hold on several phase I trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML), according to Seattle Genetics, the manufacturer of the antibody-drug conjugate. In late December 2016, the FDA enacted the clinical holds following the deaths of 4 patients who were treated with vadastuximab talirine along with allogeneic stem cell transplant (ASCT) either prior to or following treatment. Specifically, the FDA … (leggi tutto)