FDA Wants Safer Cancer Drugs, But Some Startups Fear Unintended Consequences

The pharmaceutical industry has traditionally employed a "more-is-more" approach to dosing cancer drugs in clinical trials, often resulting in higher doses than necessary. The Food and Drug Administration (FDA) is urging drugmakers to reconsider this strategy, expressing concerns about excessive side effects associated with high doses. To address this, the FDA launched Project Optimus in 2021, requiring companies to re-evaluate their dosing approaches. This initiative involves larger clinical trials to determine optimal doses that balance safety and efficacy. While entrepreneurs support the goal of finding the most effective dosage, some fear the increased time and cost associated with these trials will disadvantage startups compared to larger competitors. The FDA assures drugmakers that it encourages discussions about dosing plans and that the agency remains committed to facilitating the timely delivery of new medications to patients.