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: