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Challenges With Including PROs in Oncology Product Labels
The debate over including patient reported outcomes on oncology drug labels continues. The FDA expects well-defined and validated measurement tools and the patient community wants patient experiences to find their way to the label.
Industry, the FDA, and patient groups agree that patient-reported outcomes (PROs) should be included in labeling for oncology products, but there is not consensus on how to do so.
The various stakeholders met in a panel discussion last year at the plenary session of the annual Accelerating Anticancer Agent Development and Validation Workshop in Bethesda, MD, where frustrations were aired and frank views were exchanged.
A report of their discussion was published recently in JAMA Oncology. PRO-based claims are now included in the labeling of as many as 25% of new drug products in the United States, but only 1 of 43 oncology products approved by the FDA between 2006 and 2013 carry such claims.
Read the complete article at Cancer Therapy Advisor: http://bit.ly/1ApmQBf
EMBARK Data Show Continued Improvements With DMD Gene Therapy
March 19th 2025Data from the EMBARK trial of delandistrogene moxeparvovec in patients with Duchenne muscular dystrophy (DMD) show that benefits in functional outcomes, gene expression, and muscle imaging persist 2 years after receiving the gene therapy.
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