Accelerated Approval Could Spur Development Of Patient-Reported Outcomes Tools

26 Mar 2012

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.

FDA’s accelerated approval mechanism could serve as an impetus for sponsors to develop validated, patient-reported outcomes instruments in difficult-to-treat populations.

That was a subtle takeaway message from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline PLC’s Votrient...