US FDA Uses PI3K Inhibitor Experience To Spell Out What It Wants In Dose Optimization Studies

 
• By Sue Sutter

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.

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FDA wants oncology sponsors to get a clearer picture of the safety, tolerability and efficacy of multiple doses earlier in development. • Source: Shutterstock

The US Food and Drug Administration’s Oncology Center of Excellence used the recent advisory committee review of safety concerns with phosphatidylinositol 3-kinase (PI3K) inhibitors to publicly spell out its expectations for dose optimization studies under Project Optimus.

Those expectations include more comprehensive dose escalation studies with more patients and longer periods of observation, to be followed by...

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