Amgen Provides Updated Information On LUMAKRAS™ (Sotorasib)¹ Dose Comparison Study
Amgen announced a collaboration with the FDA to conduct a multi-center clinical trial comparing the safety and efficacy of LUMAKRAS™ at 960 mg once daily versus a lower dose of 240 mg. This trial, part of the ongoing development program, is expected to yield results by late 2022. Amgen states there will be no impact on the ongoing priority review timelines for LUMAKRAS™. Forward-looking statements caution that actual results may differ due to numerous risks and uncertainties, particularly regarding clinical trials and regulatory approvals.
- Agreed to conduct a trial comparing LUMAKRAS™ doses, which may enhance product understanding and safety profile.
- No expected impact on the ongoing priority review timeline for LUMAKRAS™.
- Dependence on clinical trials may introduce delays or uncertainties in product approval.
- Uncertainties regarding future market performance and regulatory outcomes.
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.
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™.
Amgen Forward-Looking Statements
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CONTACT: Amgen, Thousand Oaks
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
Telephone 805-447-1000
www.Amgen.com
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060 (investors)
1The trade name LUMAKRAS™ is provisionally approved for use by the U.S. FDA
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FAQ
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