Merck’s Quality-Of-Life Argument For Ridaforolimus Draws ODAC Tongue-Lashing
Executive Summary
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.
You may also be interested in...
Oncology Experience With PROs
There has been some success in getting PRO data into oncology labeling, but also notable failures.
Accelerated Approval Could Spur Development Of Patient-Reported Outcomes Tools
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.
Rezafungin Review Highlights US FDA’s ‘Flexible Development' Approach For Antimicrobials
Cidara developed the antifungal for candidemia/invasive candidiasis pursuant to the FDA’s 2017 ‘Unmet Need guidance,’ which provides an avenue for approval with a 'limited use' indication based on a streamlined development program. Some of the guidance recommendations also have been leveraged under the LPAD pathway.