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Amgen Provides Updated Information On LUMAKRAS™ (Sotorasib)¹ Dose Comparison Study

Amgen (NASDAQ:AMGN) today announced that it agreed last night with the FDA's proposed post-marketing requirement to conduct, as part of the ongoing development program, a multi-center randomized clinical trial to compare the safety and efficacy of LUMAKRAS™ at 960 mg once daily versus a lower daily dose of the drug.  Based on the preclinical, pharmacokinetic, and clinical data, Amgen intends to proceed with the previously disclosed study comparing 960 mg once daily to a 240 mg once daily dose. 

Amgen anticipates the results from the study in late 2022 and does not expect any impact on the timelines of the ongoing priority review of LUMAKRAS™.     

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Last Updated: 28-Apr-2021