"Risk Reduction" Indications Face A Higher Bar For Approval, May Require Specialized Prescribers
Executive Summary
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.
You may also be interested in...
Can Wealth Of Molecular Data Enable Promise Of Chemoprevention?
The same advances in scientific understanding of the molecular basis of cancer that have propelled the rise of targeted oncologics also hold out the tantalizing prospect of expanded chemoprevention in cancer, the American Association for Cancer Research suggests in its Cancer Progress Report 2011.
Can Wealth Of Molecular Data Enable Promise Of Chemoprevention?
The same advances in scientific understanding of the molecular basis of cancer that have propelled the rise of targeted oncologics also hold out the tantalizing prospect of expanded chemoprevention in cancer, the American Association for Cancer Research suggests in its Cancer Progress Report 2011.
Prostate Cancer Prevention Endpoint May Have Been Key Problem As ODAC Votes Down BPH sNDAs
The problems that GlaxoSmithKline and Merck had in trying to convince FDA's Oncologic Drugs Advisory Committee to add labeling on prostate cancer risk reduction to Avodart (dutasteride) and Proscar (finasteride) may have been avoided had the firms selected a stronger mortality endpoint for their trials.