From the Journals

Oncology postmarketing requirements mostly on schedule


Key clinical point: Of 49 oncology drugs approved by the FDA from January 2011 to December 2016, 23 were given accelerated approval, with 17 needing postmarketing research.

Major finding: None of the pending or ongoing studies are behind their original schedules.

Study details: A review of the FDA’s Novel Drugs Summary, the FDA’s Postmarket Requirements and Commitments database, and information.

Disclosures: No disclosures were reported.

Source: Nabhan C et al. JAMA Oncol. 2018 May 10. doi:10.1001/jamaoncol.2018.0610.



“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. doi: 10.1001/jamaoncol.2018.0610.

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