Oncology Experience With PROs
There has been some success in getting PRO data into oncology labeling, but also notable failures.
You may also be interested in...
A subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma was that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement.
The pivotal study failed to capture patient-reported outcomes data on drug-related side effects, and use of observational data to support the view that the mTOR inhibitor has a positive risk/benefit profile is “crazy,” committee members said.
Jakafi is the first approved treatment for myelofibrosis, a rare bone marrow cancer, but Incyte will also be able to claim efficacy against the symptoms of the disease thanks to data in labeling from a patient-reported outcomes tool.