[Comment] Overall survival assessment in cancer drug trials: a luxury or a necessity?

In August, 2025, the US Food and Drug Administration (FDA) published a draft guidance on the assessment of overall survival in randomised cancer drug trials.1 In essence, the guidance states that overall survival and quality of life are the only clinical endpoints to confirm the benefit of any cancer therapies—ultimately, patients want longer and better lives as a trade-off for the toxic effects of treatment. However, in recent years the FDA has deprioritised the need to show an overall survival improvement from new cancer drugs, with several new cancer drugs receiving full approval on the basis of improvements in putative surrogate endpoints alone, often in the face of negative overall survival results.