FDA Will Revisit Appropriate Use Of PFS Endpoints At Advisory Committee
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA Office of Oncology Drug Products Director Richard Pazdur plans to convene an advisory committee meeting to clarify standards for use of progression-free survival data, a move prompted by industry's aggressive adoption of the surrogate endpoint and, more broadly, the gradual decline in the level of drug benefit that sponsors seek to use in support of a cancer drug approval