SILVER SPRING, Md. -- A light-activated focal therapy for early prostate cancer failed to win over an FDA advisory committee in a bid for market approval. By a 13-2 vote, the Oncologic Drugs Advisory Committee (ODAC) declined to recommend TOOKAD VTP for approval. The FDA is not bound by committee decisions but follows the recommendations more often than not. TOOKAD, developed by Luxembourg-based Steba Biotech, consists of an infusion of padeliporfin di-potassium (derived from an aquatic bacteria), followed by intraprostatic laser activation. Activated TOOKAD leads to a cascade of events involving oxygen radicals, hypoxia, nitric oxide radicals, and endothelin-1, which causes vascular occlusion and, ultimately, self-propagating tumor cell necrosis. Questions about the therapy's pivotal trial design, endpoints, missing data, and adverse events all contributed to the negative vote. Nonetheless, some ODAC panelists expressed ambivalence about their votes. "I get the sense tha...