Wilex, FDA agree on next trial for Redectane

Wilex AG (Xetra:WL6) reached an agreement with FDA to conduct a second Phase III trial of Redectane that will evaluate the product's diagnostic performance instead of its effect on clinical outcomes. The decision is in line with a July recommendation from the Oncologic Drugs Advisory Committee (ODAC) that sensitivity and specificity could be used as primary endpoints in a Phase III trial of a test for clear cell renal cell carcinoma (RCC). FDA had asked Wilex to participate in the ODAC meeting after saying in 2011 that the company should conduct an outcomes study of the radiolabeled mAb against carbonic anhydrase IX (CAIX) prior to submitting a BLA. Redectane has completed one Phase III trial that evaluated sensitivity and specificity. ...