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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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FDA’s “Project Optimus” draft guidance on dose optimization is in the works.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.
FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.