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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.

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