Patient-Reported Outcomes in Oncology: The Jakafi and Zytiga Exceptions

Oncology is the biggest area of biopharmaceutical R&D where patient-reported outcomes are not routinely collected during clinical trials. There are some good reasons why. Jakafi and Zytiga remain outliers oncology treatment with a PRO in the approved label.

When Incyte Corp.’s Jakafi (ruxolitinib) was approved in 2011 for the rare bone marrow cancer myelofibrosis, the use of a patient-reported outcome as a secondary endpoint was headline news.

While Jakafi’s primary endpoint was spleen shrinkage, Incyte also used a modified Myelofibrosis Symptom Assessment Form 2.0 diary to measure...

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