A PROfessional trial

Cancer companies have struggled to gain FDA approvals based on patient-reported outcomes, or even to get data from a PRO instrument on a drug's label. Incyte Corp. accomplished both in November with Jakafi ruxolitinib for myelofibrosis, and the agency says other companies would be wise to follow the biotech's example.

The Jakafi experience shows how patient-reported outcome (PRO) tools should be integrated into drug development programs and rebuts concerns that doing so requires large investments of time or money, according to Richard Pazdur, director of FDA's Office of Hematology Oncology Products...