“Recently, the FDA has been criticized for its oversight of PMR clinical studies. The agency has come under fire for failure to penalize sponsors for PMR clinical studies completed late,” the authors wrote. “Our own review of PMR clinical studies for novel oncology drug products granted AA [accelerated approval] within the last 6 years found that no studies were behind their original schedules.”
“However,” they went on to note, “PMR studies identified serious safety concerns in two incidents that resulted in changes to the labeling for both products [idelalisib and ponatinib]. In addition, our analysis identified three instances [20%] where confirmatory PMR clinical studies for drugs granted AA failed to meet their primary efficacy end points.”
No disclosures were reported
SOURCE: Nabhan C et al. JAMA Oncol. 2018 May 10. .