Recognizing rare diseases' impracticability of having extensive clinical trials necessary for regulatory approval, the US Orphan Drug Act appropriately facilitates the commercialization of "orphan drugs". However, even common cancers also have rather specific but uncommon clinical situations for which extensive clinical trials are hardly practicable. Moreover, although such very costly and extensive trials often depend on industry support, uncommon situations are unattractive. Eventually, many specific treatments for designated clinical oncology situations often lack regulatory approvals...
Recognizing rare diseases' impracticability of having extensive clinical trials necessary for regulatory approval, the US Orphan Drug Act appropriatel...