newsFDA Approvalsoncology
Limited Direct Comparison of Me-Too Oncology Drugs with First-in-Class Agents: Clinical Implications and Regulatory Considerations
By MedXY|Sep 30, 2025
Analysis of FDA approvals from 2009–2020 reveals only 29% of next-in-class oncology drugs underwent head-to-head RCTs against originals, with just 22% showing survival benefits, highlighting a need for incentivized comparative trials.
