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In light of the 2024 Shkreli Awards, how do you address patient concerns regarding the 240 mg versus 960 mg dose of sotorasib?
There are some data indicating the 240 mg daily dose may offer similar (though not statistically equivalent) oncologic outcomes with reduced symptoms and reduced financial toxicity, compared to the standard 960 mg dose [Hochmair et al., PMID 39029295]. This finding has recently been more publicized with the 2024 "Shkreli Awards" in which Amgen's decision to pursue approval for the 960 mg dose is portrayed as profit-motivated. How do you discuss this data and developments with patients who express concerns they are potentially being overdosed?
Answer from: Medical Oncologist at Academic Institution
The randomized dose comparison study of sotorasib 960 mg versus 240 mg was conducted as part of an initiative from the US FDA Project Optimus, based on observations in the early phase dose-escalation study demonstrating non-dose proportional increases in drug exposure at dose levels of about 180 mg ...
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