Pfizer’s Ibrance And The Realities Of 'Real-World' Evidence
Executive Summary
US FDA approved expanded label for male breast cancer based on a supplement that included only non-traditional data sets. But agency is making clear that the “substantial” evidence for efficacy still came from the traditional pivotal trials – in women.
You may also be interested in...
FDA Is ‘Getting More Aggressive’ In Going After Drug Efficacy Claims Outside Label
Regulatory experts note there has been an uptick in enforcement letters objecting to efficacy presentations in Rx drug promotions that are not consistent with FDA-required labeling. Panelists at FDLI meeting also discuss the use of real-world evidence in prescription drug promotion.
RWE’s Biggest Role In US FDA Approvals: External Controls For Breakthrough Rare Disease Therapies
Despite broad interest, real-world evidence of efficacy in FDA decisions remains largely limited to orphan diseases and natural history, a Pink Sheet analysis shows.
US FDA's Temple On Real-World Evidence: 'I Find The Whole Thing Very Frustrating'
CDER deputy director for clinical science reiterates his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims.