FDA Oncology Panel To Weigh Independent Review Of PFS Event Subset

04 Jun 2012

The Oncologic Drugs Advisory Committee’s July 24 meeting to discuss the merits of independent radiological review of progression assessments in a pre-specified subgroup of patients, instead of 100% of all assessments, comes three years after the agency signaled it was open to considering such an approach.

An FDA Oncologic Drugs Advisory Committee endorsement of alternatives to 100% independent radiological review of progression-free survival events could reduce the clinical trial burden in some cancer settings.

During the afternoon of its July 24 meeting, ODAC will discuss use of independent audits of investigator progression assessments in...