Pidilizumab: FDA hold

FDA placed a partial clinical hold on an open-label, international, pivotal Phase II trial evaluating pidilizumab after Medivation alerted FDA the product is not an inhibitor of PD-1 as reflected in study literature. FDA requested revised investigator brochures, protocols and informed consent documents, which Medivation plans to submit this month. The company said it is working to determine pidilizumab’s mechanism of action. ...