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

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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.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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