The US FDA Accelerated Approval of sotorasib required the sponsor to conduct a randomized trial that compared the safety and efficacy of the approved dose with a lower dose. These results, recently disclosed, have important implications for patients, payers, oncologists and the pharmaceutical industry.
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G.W.S. is an employee of the US Department of Veterans Affairs; the views expressed do not reflect those of the US federal government. G.W.S. has received consulting fees from EBSCO Information Systems and VIVIO Health, and is a co-inventor in a filed method-of-use patent in dose optimization (held by the Department of Veterans Affairs and the University of Michigan; for which he receives no royalties). G.W.S. and M.J.R. are co-inventors in a filed method-of-use patent in dose optimization of tocilizumab for viral infections (held by the University of Chicago; for which they receive no royalties), and are directors of the Optimal Cancer Care Alliance, an Ann Arbor, MI, USA-based 501(c)3 non-profit organization.
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Strohbehn, G.W., Ratain, M.J. Sotorasib dosing and incremental cost ineffectiveness — implications and lessons for stakeholders. Nat Rev Clin Oncol 21, 331–332 (2024). https://doi.org/10.1038/s41571-024-00862-6
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DOI: https://doi.org/10.1038/s41571-024-00862-6
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