ESMO discussants urge physicians to prescribe lower dose of Amgen’s sotorasib

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Experts in pharmacology and lung cancer urged physicians to prescribe the Amgen agent Lumakras (sotorasib) at the lowest tested dose—240 mg—instead of the four times higher dose of 960 mg recommended by the sponsor.

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Paul Goldberg
Editor & Publisher
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To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
Paul Goldberg
Editor & Publisher