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PRO-fessional label

How a new PRO could end up on cancer drug labels

Data on cancer drug labels provide information on objective efficacy outcomes, but they don't help patients understand the profound impact of treatment decisions on quality of life. That could change within the next couple of years, when FDA expects to see data included on labels from a patient-reported outcome tool that assesses symptomatic toxicities.

The new tool is the PRO-CTCAE, an adaptation of an instrument used for decades by clinicians to assess adverse events in clinical trials. NCI launched it as an online tool April 1 after gathering input from FDA and patient groups and testing the tool via industry and academic collaborations.

FDA recognizes the need to get patient-reported outcomes (PROs) on cancer drug labels, but existing tools are not adequate to capture data of sufficient quality to put on drug labels.

"A drug's effect on symptoms of the disease, the symptomatic adverse events or toxicities, and its impact on physical function, these are all very important to patients," said Paul Kluetz, associate director at FDA's Office of Hematology and Oncology Products.

Only one cancer drug - Jakafi ruxolitinib from

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