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.