Slow Down To Speed Up: US FDA Presses Cases For Dose Optimization
The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.
You may also be interested in...
Early approvals may not be feasible for all submissions due to specific issues with an application or overall workload considerations, FDA says in a new draft guidance on the RTOR program; agency recommends bundling components of an RTOR application in a maximum of three partial submissions and a final submission.
US FDA cancer chief Rick Pazdur plans to send industry to ‘rehab’ with Project Frontrunner, which will push for development of cancer drugs in randomized controlled trials in earlier disease. Goal is to reduce time of uncertainty between accelerated approval and confirmatory evidence.
In exploratory FDA analyses, PRO data appeared more sensitive at detecting an exposure-toxicity relationship for an oral small molecule cancer drug than clinician-reported data; Project Optimus representative dispels industry concerns that FDA wants firms to find the 'mythical' optimal dose.