On April 28, 2021 Amgen (NASDAQ:AMGN) reported 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 (Press release, Amgen, APR 28, 2021, View Source [SID1234578701]). 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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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.