Vadastuximab talirine: Ph I/II hold

Seattle Genetics said FDA placed a full clinical hold on an open-label, U.S. Phase I/II trial of vadastuximab talirine monotherapy given before or after an allogeneic hematopoietic stem cell transplant (HSCT) in about 102 AML patients after reports of hepatotoxicity in 6 patients receiving the product. The company said there were 4 deaths and "several" cases of veno-occlusive disease.

The agency also placed partial holds on 2 open-label, U.S. Phase I trials of the product in AML patients. One as monotherapy with a subset of older AML patients also receiving hypomethylating agents and the other evaluating vadastuximab talirine in combination with chemotherapy in younger, newly diagnosed AML patients. The latter 2 trials will suspend enrollment but continue to treat existing patients...