Improving accelerated approval

FDA's Division of Oncology Products is considering new approaches for approving cancer therapeutics, including the development of new endpoints and changes to the accelerated approval paradigm.

The division's thinking is outlined in an unpublished paper "Endpoints and FDA Approval of Oncology Drugs," written by Director Richard Pazdur, Deputy Director Grant Williams, and Lead Medical Officer John Johnson, who provide insights into the types of designs that are likely to succeed or fail as pivotal studies for approval of cancer products...