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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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.
No Excuses: US FDA Wants Early, Thorough Dosage Optimization For Cancer Drugs
Breakthrough therapy designation is not a sufficient reason to avoid identifying an optimal dosage prior to submitting a marketing application, agency says in draft guidance under Project Optimus. Guidelines also emphasize randomized comparisons of multiple dosages and exploration of tolerability issues.
US FDA Uses PI3K Inhibitor Experience To Spell Out What It Wants In Dose Optimization Studies
Advisory committee review of safety issues with the PI3K inhibitor class of drugs for hematologic malignancies served as a platform for the Oncology Center of Excellence’s Project Optimus initiative, which emphasizes an earlier and more thorough assessment of different doses, including through randomized trials.