Many FDA approved drugs fail to deliver on OS, PRO benefit
medwireNews: An analysis of oncology drugs approved by the US FDA shows that nearly half have not shown improvements in either overall survival (OS) or patient-reported outcomes (PROs).
Of the 65 drugs that were approved for 71 oncology indications in 2011–2017, there was evidence of an OS benefit for 15 of the indications at the time of approval (median gain, 1.7 months), with an additional eight demonstrating an improvement over a median of 4.1 years after approval.
At the time of analysis, failure to improve OS had been shown for 18% of the approvals, while the effect on OS had not yet been determined for the remaining 49%.
“In the absence of OS benefit, an argument can be made that novel oncology drugs might provide patients with better quality of life,” say the study authors.
But only a quarter of the indications were associated with a PRO benefit. Specifically, PROs were evaluated during the pivotal trials for 50 indications, with 14 showing a significant improvement for at least one outcome, while a further four drugs demonstrated a PRO benefit in the post-approval period.
Writing in a research letter to JAMA Oncology, Chadi Nabhan (Aptitude Health, Atlanta, Georgia, USA) and co-authors note that their findings are similar to those of a study evaluating oncology drug approvals by the EMA.
And they continue: “Where possible, the requirement for postmarketing studies confirming an OS benefit, enforcement of timely completion of the studies, and action should those studies fail to show a benefit represents one avenue by which the FDA could improve the number of oncology drugs that provide true meaningful benefits to patients.”
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