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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The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June 2021, when FDA announced in its accelerated approval of the KRASG12C inhibitor sotorasib that it would require a randomized, controlled trial comparing the efficacy of the labeled dose (960 mg once daily) to a 75% lower dose (240 mg once daily) as a condition of full regulatory approval (The Cancer Letter, June 11, 2021; April 29, 2022).
Paul Goldberg
Editor & Publisher