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 avoid intolerable side effects. For years, Food and Drug Administration officials have expressed concern that cancer drug doses are often too high, leading to unnecessary side effects.

An FDA program launched in 2021, Project Optimus, requires companies to re-examine how they set doses of cancer treatments. This typically involves larger clinical trials to test doses to find those that optimally balance safety and efficacy. 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. The FDA says it encourages drugmakers to discuss dosing plans with the agency and that new medications can still be brought to patients quickly.

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