"Risk Reduction" Indications Face A Higher Bar For Approval, May Require Specialized Prescribers

Drugs that are intended to reduce the risk of cancer in a healthy population must meet a much higher bar than therapies for cancer patients, a bar that GlaxoSmithKline's Avodart (dutasteride) and Merck's Proscar (finasteride) failed to meet because they actually seemed to increase the risk of high-grade prostate cancers, FDA's Oncologic Drugs Advisory Committee said in a pair of lopsided votes Dec. 1.