End Points and United States Food and Drug Administration Approval of Oncology Drugs

摘要: Purpose: To summarize the end points used by United States Food and Drug Administration (FDA) to approve new cancer drug applications over last 13 years. Materials Methods: The FDA granted marketing approval 71 oncology between January 1, 1990, November 2002. as basis for each application are presented, rationale point is discussed. Results: grants either regular or accelerated applications. Regular based on that demonstrate provides a longer life, better favorable effect an established surrogate life life. Accelerated (AA) less well but reasonably likely predict Tumor response was in 26 of 57 approvals, supported relief tumor-specific sympto...