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Ann T. Farrell and Richard Pazdur

The U.S. Food and Drug Administration facilitates the development of drugs intended to treat cancer and other serious or life-threatening diseases. This article describes the new drug application (NDA) process, endpoints used in oncologic trials, and recent initiatives to expedite the review of drugs used to treat serious and life-threatening diseases. The Food and Drug Administration can grant either regular or accelerated marketing approval for oncology drugs. Regular approval is based on endpoints demonstrating that the drug provides a clinical benefit, such as longer life, enhanced quality of life, or a favorable effect on an established surrogate for longer or better life, such as long-term complete responses. Accelerated approval is based on a surrogate endpoint that is less well established but is reasonably likely to predict a longer or better life and can be granted for drugs that are intended to treat a serious or life-threatening illness and that provide meaningful therapeutic benefit to patients over existing therapies. The Agency classifies an NDA as either a priority or a standard application. Drugs that receive priority review are agents that appear to represent significant improvements over existing therapies. A priority NDA is reviewed by the Agency within 6 months; a standard review is accomplished within 10 months. The Agency communicates with sponsors throughout the drug development process, suggesting appropriate trial designs and meaningful endpoints.