Premarket Dose Optimization Precedent In Oncology Likely Not Available Yet
The current crop of cancer drug approvals were well along in development when Project Optimus launched, meaning they may not have been able to implement the Oncology Center of Excellence’s premarket dose optimization policy.
You may also be interested in...
The push for dose optimization in oncology should incorporate patient experience data, a Friends of Cancer Research White Paper recommends. ‘Tolerability’ is a key element to define in early development, and patient-reported outcomes can help.
FDA initiative aimed at optimizing cancer drug dosage earlier in development started with single-agent therapies, but moving into combinations is ‘a natural progression,’ Oncology Center of Excellence’s Richard Pazdur says. At a recent workshop, experts discuss considerations for combination product dosage optimization and review case studies that reflect Optimus principles.
Pediatric studies of promising cancer drugs can begin before the ideal dose is identified for adults, although some dose optimization work in children may be better left to the postmarket setting, advisory committee members said.