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Amgen Provides Updated Information On LUMAKRAS™ (Sotorasib)¹ Dose Comparison Study
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THOUSAND OAKS, Calif., April 28, 2021 /PRNewswire/ 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.
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