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.
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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.
A single-item instrument can capture cumulative effects of low-grade drug toxicities, informing dose selection and de-risking development programs. However, administration of those measures at baseline in treatment-naïve patients is problematic, and practical challenges and regulatory uncertainties have inhibited broad adoption by sponsors, FDA workshop participants say.
US FDA Cancer Drug Dosage Optimization Guidance Will Increase Exposure To Ineffective Agents, NCI Says
Draft recommendations would lead to enrolling additional patients on multiple dose levels to assess activity before clinical effectiveness has been established, National Cancer Institute says; industry cites need for flexibility in recommending randomized studies of multiple dosages and questions utility of PRO data in early dose finding studies.