Medivation's pidilizumab on partial clinical hold

Medivation Inc. (NASDAQ:MDVN) said FDA placed a partial clinical hold on an IND for pidilizumab ( MDV9300) after the company disclosed the candidate is not an inhibitor of PD-1, as it had thought. FDA told Medivation to revise statements in an investigator brochure, protocols and informed consent documents. Medivation said it is working to determine pidilizumab's mechanism of action.

Medivation has not yet enrolled any patients in a Phase II trial it began last month to treat relapsed or refractory diffuse large B cell lymphoma. Patients in investigator-sponsored studies will continue to receive pidilizumab, and the company said it must ask investigators to update study protocols to specify that the candidate is not an antibody against PD-1. ...