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Vol. 20/No. 18

Conflicting guidelines on prostate-specific antigen testing have affected trends on disease presentation and, potentially, the treatment outcomes for many men with this disease. New agents and powerful new imaging tools have added yet more complexity to the decision process. Therefore, more investigation and cooperation on multiple levels is needed to define appropriate standards of care.

With the revolution in our understanding of cancer’s basic molecular biology, it is increasingly evident that subgroups of cancer originating from specific regions of the body have unique natural histories and respond to very different therapeutics. For example, the importance of BRCA mutations, which define a subset of ovarian cancers impressively sensitive to PARP inhibitors, has striking altered the management of this group of gynecologic malignancies.

Given the widespread financial impact the high cost of cancer drugs has on the healthcare system, it may be time for the FDA to take a broader approach when reviewing oncology drug applications. By also examining the cost of the drug, the FDA could shine a light on escalating drug costs and play a leadership role in creating new programs and initiatives that help patients pay for promising new therapies.