Only 29% of FDA-approved next-in-class oncology drugs (me-too drugs) from 2009 to 2020 were evaluated in head-to-head randomized clinical trials (RCTs) against first-in-class agents.
Among these direct comparisons, only 22% of me-too drugs demonstrated a survival benefit over the original drugs.
Most trials used progression-free survival as the primary endpoint, with limited emphasis on overall survival.
There is a pressing need for regulatory incentives to promote within-class RCTs to better assess true therapeutic value.
