Appropriate statistical methods are available to handle biases encountered in blinded, independent, central review (BICR) determined progression-free survival

While overall survival (OS) has traditionally been the standard evaluation for a new treatment in oncology since it is easily obtained and unambiguous, the endpoint of progression-free survival (PFS) is appealing due to the shortened observation time required to determine treatment efficacy, smaller sample size requirements and no confounding due to subsequent treatments. For many cancers, PFS has been demonstrated to be a valid measure of surrogacy for OS and an acceptable trial endpoint from regulatory agencies (1).