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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References
US Food and Drug Administration. FDA grants accelerated approval to sotorasib for KRAS G12C mutated NSCLC. fda.gov, https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sotorasib-kras-g12c-mutated-nsclc (2021).
Zhao, D., Liu, Y., Yi, F., Zhao, X. & Lu, K. Recent advances in the development of inhibitors targeting KRAS-G12C and its related pathways. Eur. J. Med. Chem. 259, 115698 (2023).
US Food and Drug Administration. FDA Briefing Document: Oncologic Drugs Advisory Committee Meeting, October 5, 2023. NDA 214665 s005, Sotorasib; Amgen, Inc. (FDA, 2023).
Amgen, Inc. Background Information for the Oncologic Drugs Advisory Committee. 05 October 2023. Supplemental New Drug Application for Sotorasib (Amgen Inc., 2023).
Amgen. Amgen provides regulatory update on status of lumakras (sotorasib). PR Newswire, https://www.prnewswire.com/news-releases/amgen-provides-regulatory-update-on-status-of-lumakras-sotorasib-302022131.html (2023).
Glaxo-Smith-Kline. Information for Vermont prescribers of prescription drugs. pricedisclosure.gsk.com, https://www.pricedisclosure.gsk.com/PriceDisclosure/DrugDetails?Ahfscc_tc_cd=10000000&Brod_nm=ZEJULA&Genr_nm=%28niraparib%29&Dos_fm=Tablets (accessed 14 December 2023).
Amgen, Inc. 2022 Q4 earnings call transcript. CapEdge, https://capedge.com/transcript/318154/2022Q4/AMGN (accessed December 14, 2023).
Szmulewitz, R. Z., Stadler, W. M. & Ratain, M. J. The abiraterone dosing chess match with Johnson & Johnson-back in check. JAMA Oncol. 7, 827–828 (2021).
Johnson, C. Y. After outcry, drugmakers decide not to triple the price of a cancer pill. Washington Post, https://www.washingtonpost.com/news/wonk/wp/2018/05/15/after-outcry-drugmakers-decide-not-to-triple-the-price-of-a-cancer-pill/ (2018).
CNBC. Bristol-Myers Squibb to acquire Mirati in up to $5.8 billion deal. CNBC, https://www.cnbc.com/2023/10/08/bristol-myers-squibb-to-acquire-mirati-in-a-4point8-billion-deal.html (2023).
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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
