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FDA Wants Safer Cancer Drugs, But Some Startups Fear Unintended Consequences
For decades drugmakers have taken a more-is-more model when dosing cancer drugs in clinical trials. U.S. regulators want them to reconsider that approach. From a report: Companies with cancer drugs in clinical trials must strike a balance between doses high enough to thwart tumors, but low enough to...
From a report: Companies with cancer drugs in clinical trials must strike a balance between doses high enough to thwart tumors, but low enough to avoid intolerable side effects. An FDA program launched in 2021, Project Optimus, requires companies to re-examine how they set doses of cancer treatments. Entrepreneurs support the aim, but some fear the initiative will add time and cost to drug development, putting startups at a further disadvantage to larger competitors.
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