oncology – Medxy AI

Limited Direct Comparison of Me-Too Oncology Drugs with First-in-Class Agents: Clinical Implications and Regulatory Considerations

By MedXY 07/31/2025

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.