US FDA Oncology Center Makes Dose Optimization Personal
Executive Summary
‘Project Optimus’ is continuing to press forward on reframing the approach to dosing of anticancer drugs. The initiative is very personal to OCE Director Richard Pazdur.
You may also be interested in...
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.
Cancer Drug Dose Optimization Benefits Include Better Pivotal Trial Retention, Fewer Clinical Holds
US FDA is asking oncology sponsors for randomized studies comparing at least two doses early in development; despite concerns about delaying approval, FDA and industry reps say approach will increase success of registrational trials and reduce likelihood of market withdrawal due to toxicity.
US FDA’s ‘Project Optimus’ Will Encourage Move Away From Conventional Dose-Finding For Modern Cancer Therapies
Simply carrying forward the maximum tolerated dose into later-stage trials does not account for the importance of long-term tolerability – and the fact that higher doses are not necessarily better for patients.