FDA Halts Several Trials of Vadastuximab Talirine in AML

27 dicembre 2016 – The FDA has placed clinical holds 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. The clinical holds followed 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 wants to assess the risk of hepatotoxicity, as … (leggi tutto)