Amgen’s Sotorasib Updates Raise New Questions For KRAS Program
Lower Dose Being Tested Against Higher Dose Under FDA Review
The company provided updates on the timing of some data from its extensive clinical program for its KRAS G12C inhibitor Lumakras, but not for certain high-profile combinations.
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Project Protect is the Oncology Center of Excellence’s latest program to support cancer drug development; the safety signal tool has been used to support 44 drug applications.
Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.
FDA’s “Project Optimus” draft guidance on dose optimization is in the works. Until then, randomized dosing studies need to be an IND-level conversation.